Trial Outcomes & Findings for A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) (NCT NCT03248492)
NCT ID: NCT03248492
Last Updated: 2025-06-26
Results Overview
The number of participants with objective response was assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment, by independent central imaging facility review based on RECIST version 1.1.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
253 participants
Primary outcome timeframe
at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)
Results posted on
2025-06-26
Participant Flow
Participants who met all of the inclusion and none of the exclusion criteria were enrolled and randomized to treatment (Part 1) or received DS-8201a at the recommended dose (Part 2).
In Part 1, participants were randomized 1:1:1 to either 5.4 mg/kg, 6.4 mg/kg, or 7.4 mg/kg dose of DS-8201a. Two doses randomized 1:1 (5.4 or 6.4 mg/kg) were further evaluated. In Part 2, all T-DM1 resistant refractory participants (cohort 2a) or T-DM1 intolerant (cohort 2b) received DS-8201a at the recommended dose.
Participant milestones
| Measure |
Part 1: DS-8201a Low Dose
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a Medium Dose
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a High Dose
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phase.
|
Part 2a: DS-8201a Low Dose
All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.
|
Part 2b (Exploratory): DS-8201a Low Dose
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 2b in the continuation phase.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
21
|
130
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
50
|
48
|
21
|
130
|
4
|
Reasons for withdrawal
| Measure |
Part 1: DS-8201a Low Dose
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a Medium Dose
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a High Dose
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phase.
|
Part 2a: DS-8201a Low Dose
All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.
|
Part 2b (Exploratory): DS-8201a Low Dose
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 2b in the continuation phase.
|
|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
24
|
23
|
11
|
66
|
1
|
|
Overall Study
Adverse Event
|
14
|
13
|
9
|
22
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
0
|
8
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
7
|
0
|
|
Overall Study
Death
|
1
|
1
|
0
|
6
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
3
|
1
|
0
|
7
|
0
|
|
Overall Study
Other
|
2
|
5
|
0
|
14
|
0
|
Baseline Characteristics
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Baseline characteristics by cohort
| Measure |
Part 1: DS-8201a Low Dose
n=50 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a Medium Dose
n=48 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a High Dose
n=21 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 2a: DS-8201a Low Dose
n=130 Participants
All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.
|
Part 2b (Exploratory): DS-8201a Low Dose
n=4 Participants
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 2b in the continuation phase.
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
189 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
64 Participants
n=8 Participants
|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
49.8 years
STANDARD_DEVIATION 9.2 • n=21 Participants
|
55.8 years
STANDARD_DEVIATION 11.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
253 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
104 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
132 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Region of Enrollment
South Korea
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
0 participants
n=5 Participants
|
25 participants
n=4 Participants
|
1 participants
n=21 Participants
|
40 participants
n=8 Participants
|
|
Region of Enrollment
Belgium
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
7 participants
n=4 Participants
|
0 participants
n=21 Participants
|
9 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
10 participants
n=5 Participants
|
36 participants
n=4 Participants
|
2 participants
n=21 Participants
|
77 participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
11 participants
n=5 Participants
|
14 participants
n=4 Participants
|
0 participants
n=21 Participants
|
56 participants
n=8 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
8 participants
n=4 Participants
|
1 participants
n=21 Participants
|
10 participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
12 participants
n=4 Participants
|
0 participants
n=21 Participants
|
12 participants
n=8 Participants
|
|
Region of Enrollment
France
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
17 participants
n=4 Participants
|
0 participants
n=21 Participants
|
20 participants
n=8 Participants
|
|
Region of Enrollment
Spain
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
0 participants
n=5 Participants
|
11 participants
n=4 Participants
|
0 participants
n=21 Participants
|
29 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)Population: Objective response rate (ORR) was assessed in the Enrolled Analysis Set.at data cut-off date of 21 March 2019
The number of participants with objective response was assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment, by independent central imaging facility review based on RECIST version 1.1.
Outcome measures
| Measure |
Part 1 and Part 2a: DS-8201a Low Dose
n=180 Participants
All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.
|
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
n=184 Participants
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
|
Part 1: DS-8201a Medium Dose
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a High Dose
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 2b (Exploratory): DS-8201a Low Dose
All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in the continuation phase.
|
|---|---|---|---|---|---|
|
Objective Response Rate as Confirmed by Independent Central Review Following Intravenous Administration of 5.4 mg/kg DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
|
109 Participants
|
111 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)Population: Objective response rate (ORR) was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
The number of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment. Investigator-assessed objective response rate (ORR) was defined as the proportion of participants who achieved a best overall response of complete response or partial response based on local radiologists/investigators' tumor assessments.
Outcome measures
| Measure |
Part 1 and Part 2a: DS-8201a Low Dose
n=180 Participants
All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.
|
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
n=184 Participants
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
|
Part 1: DS-8201a Medium Dose
n=48 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a High Dose
n=21 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 2b (Exploratory): DS-8201a Low Dose
All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in the continuation phase.
|
|---|---|---|---|---|---|
|
Objective Response Rate as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
|
116 Participants
|
118 Participants
|
37 Participants
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)Population: Best overall tumor response was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
Best overall tumor response was defined as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) by the investigator based on RECIST v1.1. Participants who were non-evaluable (NE) are also reported.
Outcome measures
| Measure |
Part 1 and Part 2a: DS-8201a Low Dose
n=48 Participants
All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.
|
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
n=21 Participants
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
|
Part 1: DS-8201a Medium Dose
n=180 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a High Dose
n=184 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 2b (Exploratory): DS-8201a Low Dose
All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in the continuation phase.
|
|---|---|---|---|---|---|
|
Best Overall Tumor Response as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Non-evaluable
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Best Overall Tumor Response as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Complete response
|
3 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
—
|
|
Best Overall Tumor Response as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Partial response
|
34 Participants
|
18 Participants
|
112 Participants
|
112 Participants
|
—
|
|
Best Overall Tumor Response as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Stable disease
|
10 Participants
|
3 Participants
|
59 Participants
|
61 Participants
|
—
|
|
Best Overall Tumor Response as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Progressive disease
|
0 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)Population: Disease control rate (DCR) and clinical benefit rate (CBR) were assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
Number of participants with controlled disease and who received clinical benefit from treatment as assessed by independent central review. DCR was defined as the proportion of participants who achieved a best overall response of complete response, partial response, or stable disease. CBR was defined as the proportion of participants who achieved a best overall response of complete response or partial response or more than 6 months of stable disease.
Outcome measures
| Measure |
Part 1 and Part 2a: DS-8201a Low Dose
n=48 Participants
All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.
|
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
n=21 Participants
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
|
Part 1: DS-8201a Medium Dose
n=180 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a High Dose
n=184 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 2b (Exploratory): DS-8201a Low Dose
All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in the continuation phase.
|
|---|---|---|---|---|---|
|
Disease Control Rate and Clinical Benefit Rate as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Disease control rate
|
47 Participants
|
21 Participants
|
175 Participants
|
179 Participants
|
—
|
|
Disease Control Rate and Clinical Benefit Rate as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Clinical benefit rate
|
41 Participants
|
20 Participants
|
127 Participants
|
130 Participants
|
—
|
SECONDARY outcome
Timeframe: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)Population: Participants with CR or PR were analyzed. Estimated duration of response was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
The estimated duration of confirmed response (complete response \[CR\] or partial response \[PR\]) was assessed by independent central review. Duration of response was defined as the time interval between the date of first documentation of objective response (CR or PR) and the date of the first objective documentation of disease progression or death due to any cause.
Outcome measures
| Measure |
Part 1 and Part 2a: DS-8201a Low Dose
n=33 Participants
All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.
|
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
n=17 Participants
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
|
Part 1: DS-8201a Medium Dose
n=109 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a High Dose
n=111 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 2b (Exploratory): DS-8201a Low Dose
All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in the continuation phase.
|
|---|---|---|---|---|---|
|
Duration of Response (Complete Response or Partial Response) as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
|
NA months
Interval 8.3 to
There were not enough events to estimate a standard error for the median survival time.
|
6.0 months
Interval 4.8 to 8.3
|
NA months
Lack of a median value is due to less than 50% of the participants experiencing the event.
|
NA months
Lack of a median value is due to less than 50% of the participants experiencing the event.
|
—
|
SECONDARY outcome
Timeframe: at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)Population: Progression-free survival was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
The point estimate of progression-free survival (PFS) is reported. PFS was defined as the time interval between the date of randomization/registration and the first documentation of disease progression or death due to any cause.
Outcome measures
| Measure |
Part 1 and Part 2a: DS-8201a Low Dose
n=48 Participants
All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.
|
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
n=21 Participants
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
|
Part 1: DS-8201a Medium Dose
n=180 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a High Dose
n=184 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 2b (Exploratory): DS-8201a Low Dose
All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in the continuation phase.
|
|---|---|---|---|---|---|
|
Progression-Free Survival Estimate As Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
|
NA months
Lack of a median value is due to less than 50% of the participants experiencing the event.
|
9.5 months
Interval 7.4 to 13.2
|
NA months
Interval 10.6 to
There were not enough events to estimate a standard error for the median survival time.
|
NA months
Interval 10.6 to
There were not enough events to estimate a standard error for the median survival time.
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 6, 12, 18, 24, 30, 36 post dosePopulation: Best percent change from baseline in sum of diameters was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.
Best percent change in sum of diameters of measurable tumors was based on RECIST 1.1. The best percent change was defined as the percent change in the smallest sum of diameters from all post-baseline tumor assessments, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
Part 1 and Part 2a: DS-8201a Low Dose
n=48 Participants
All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.
|
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
n=21 Participants
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
|
Part 1: DS-8201a Medium Dose
n=180 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a High Dose
n=184 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 2b (Exploratory): DS-8201a Low Dose
All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in the continuation phase.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Sum of Diameters Over Time as Determined by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Baseline to Week 6
|
-26.2 Percent change from baseline
Standard Deviation 18.3
|
-32.9 Percent change from baseline
Standard Deviation 25.4
|
-26.9 Percent change from baseline
Standard Deviation 21.6
|
-26.9 Percent change from baseline
Standard Deviation 22.5
|
—
|
|
Percent Change From Baseline in Sum of Diameters Over Time as Determined by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Baseline to Week 12
|
-39.6 Percent change from baseline
Standard Deviation 22.7
|
-43.6 Percent change from baseline
Standard Deviation 28.1
|
-39.9 Percent change from baseline
Standard Deviation 24.5
|
-40.1 Percent change from baseline
Standard Deviation 24.9
|
—
|
|
Percent Change From Baseline in Sum of Diameters Over Time as Determined by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Baseline to Week 18
|
-50.1 Percent change from baseline
Standard Deviation 22.1
|
-58.5 Percent change from baseline
Standard Deviation 29.4
|
-44.4 Percent change from baseline
Standard Deviation 27.8
|
-44.9 Percent change from baseline
Standard Deviation 28.0
|
—
|
|
Percent Change From Baseline in Sum of Diameters Over Time as Determined by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Baseline to Week 24
|
-56.3 Percent change from baseline
Standard Deviation 22.1
|
-61.9 Percent change from baseline
Standard Deviation 32.0
|
-49.2 Percent change from baseline
Standard Deviation 30.6
|
-49.3 Percent change from baseline
Standard Deviation 30.5
|
—
|
|
Percent Change From Baseline in Sum of Diameters Over Time as Determined by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Baseline to Week 30
|
-59.1 Percent change from baseline
Standard Deviation 26.1
|
-63.9 Percent change from baseline
Standard Deviation 32.2
|
-51.2 Percent change from baseline
Standard Deviation 29.2
|
-51.5 Percent change from baseline
Standard Deviation 29.2
|
—
|
|
Percent Change From Baseline in Sum of Diameters Over Time as Determined by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Baseline to Week 36
|
-61.0 Percent change from baseline
Standard Deviation 26.7
|
-54.6 Percent change from baseline
Standard Deviation 32.2
|
-55.5 Percent change from baseline
Standard Deviation 29.9
|
-55.5 Percent change from baseline
Standard Deviation 29.9
|
—
|
|
Percent Change From Baseline in Sum of Diameters Over Time as Determined by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)
Best percent change from baseline
|
-59.5 Percent change from baseline
Standard Deviation 28.2
|
-65.3 Percent change from baseline
Standard Deviation 27.7
|
-50.5 Percent change from baseline
Standard Deviation 28.3
|
-50.6 Percent change from baseline
Standard Deviation 28.8
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 47 post last dosePopulation: Adverse event data were assessed in the Safety Analysis Set t data cut-off date of 21 March 2019.
TEAEs were assessed by severity and seriousness according to unique criteria. Severity described the intensity of an event and was graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening consequences; urgent intervention indicated; and Grade 5: Death related to AE. Serious TEAEs were defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires inpatient hospitalization, or causes prolongation of existing hospitalization.
Outcome measures
| Measure |
Part 1 and Part 2a: DS-8201a Low Dose
n=50 Participants
All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.
|
Part 1 + Part 2a + Part 2b: DS-8201a Low Dose
n=48 Participants
All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.
|
Part 1: DS-8201a Medium Dose
n=21 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a High Dose
n=130 Participants
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 2b (Exploratory): DS-8201a Low Dose
n=4 Participants
All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in the continuation phase.
|
|---|---|---|---|---|---|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
Any TEAE
|
50 Participants
|
48 Participants
|
21 Participants
|
129 Participants
|
4 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
Drug-related TEAEs
|
50 Participants
|
47 Participants
|
21 Participants
|
128 Participants
|
4 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
Drug-related TEAEs of CTCAE ≥Grade 3
|
26 Participants
|
32 Participants
|
16 Participants
|
48 Participants
|
3 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
Any serious TEAE
|
11 Participants
|
6 Participants
|
8 Participants
|
25 Participants
|
0 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
Drug-related serious TEAEs
|
6 Participants
|
4 Participants
|
5 Participants
|
10 Participants
|
0 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
TEAEs associated with drug discontinuation
|
6 Participants
|
6 Participants
|
8 Participants
|
8 Participants
|
1 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
Related TEAEs associated with drug discontinuation
|
6 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
1 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
TEAEs associated with dose reduction
|
13 Participants
|
19 Participants
|
11 Participants
|
21 Participants
|
3 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
Drug-related TEAEs associated with dose reduction
|
11 Participants
|
18 Participants
|
11 Participants
|
20 Participants
|
3 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
TEAEs associated with dose interruption
|
19 Participants
|
16 Participants
|
12 Participants
|
36 Participants
|
2 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
Related TEAEs associated with drug interruption
|
17 Participants
|
13 Participants
|
11 Participants
|
29 Participants
|
2 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
TEAEs associated with death
|
1 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
0 Participants
|
|
Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)
Drug-related TEAEs associated with death
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Part 1: DS-8201a Low Dose
Serious events: 14 serious events
Other events: 50 other events
Deaths: 33 deaths
Part 1: DS-8201a Medium Dose
Serious events: 11 serious events
Other events: 48 other events
Deaths: 30 deaths
Part 1: DS-8201a High Dose
Serious events: 8 serious events
Other events: 21 other events
Deaths: 18 deaths
Part 2a: DS-8201a Low Dose
Serious events: 42 serious events
Other events: 129 other events
Deaths: 86 deaths
Part 2b (Exploratory): DS-8201a Low Dose
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Part 1: DS-8201a Low Dose
n=50 participants at risk
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a Medium Dose
n=48 participants at risk
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a High Dose
n=21 participants at risk
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 2a: DS-8201a Low Dose
n=130 participants at risk
All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.
|
Part 2b (Exploratory): DS-8201a Low Dose
n=4 participants at risk
All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in Part 2b in the continuation phase.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.0%
3/50 • Number of events 3 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Hematuria
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Shock haemorrhagic
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • Number of events 3 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
1.5%
2/130 • Number of events 3 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Number of events 3 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.3%
3/130 • Number of events 4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
1.5%
2/130 • Number of events 2 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal abscess
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Disease progression
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 2 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Pain
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
General physical health deterioration
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Asthenia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Pyelonephritis
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
1.5%
2/130 • Number of events 2 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Immune system disorders
Hypersensitivity
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Cellulitis
|
6.0%
3/50 • Number of events 3 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.2%
2/48 • Number of events 2 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Number of events 2 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.3%
3/130 • Number of events 3 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
1.5%
2/130 • Number of events 2 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Diverticulitis
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Lung infection
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Parotitis
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Osteomyelitis
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Pneumonitis
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.3%
3/130 • Number of events 3 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.5%
2/21 • Number of events 3 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.5%
2/21 • Number of events 3 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
1.5%
2/130 • Number of events 2 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Epilepsy
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Presyncope
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Reproductive system and breast disorders
Genital hemorrhage
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
2/50 • Number of events 20 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.2%
2/48 • Number of events 2 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
1.5%
2/130 • Number of events 2 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
1.5%
2/130 • Number of events 2 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Cardiac disorders
Coronary artery disease
|
2.0%
1/50 • Number of events 2 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Gastric varices
|
2.0%
1/50 • Number of events 2 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Varices oesophageal
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
COVID-19
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Platelet count decreased
|
2.0%
1/50 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
—
0/0 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Cardiac disorders
Pulmonary valve disease
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.3%
3/130 • Number of events 4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Dehiscence
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Acute hepatitis B
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Femur fracture
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Seizure
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
Other adverse events
| Measure |
Part 1: DS-8201a Low Dose
n=50 participants at risk
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a Medium Dose
n=48 participants at risk
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 1: DS-8201a High Dose
n=21 participants at risk
T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
|
Part 2a: DS-8201a Low Dose
n=130 participants at risk
All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.
|
Part 2b (Exploratory): DS-8201a Low Dose
n=4 participants at risk
All participants who were T-DM1 intolerant and treated at the recommend dose (5.4 mg/kg) in Part 2b in the continuation phase.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
5.4%
7/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
2/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
8.3%
4/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.5%
2/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
8.5%
11/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.0%
9/50 • Number of events 37 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.6%
7/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
23.8%
5/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.0%
13/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.0%
2/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
7.7%
10/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
3.8%
5/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Eye disorders
Dry eye
|
8.0%
4/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.6%
7/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
33.3%
7/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
13.8%
18/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Eye disorders
Keratitis
|
4.0%
2/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.3%
3/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
19.0%
4/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Eye disorders
Visual impairment
|
2.0%
1/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.2%
2/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
1.5%
2/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
76.0%
38/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
83.3%
40/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
61.9%
13/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
78.5%
102/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
75.0%
3/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
46.0%
23/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
43.8%
21/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
38.1%
8/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
46.9%
61/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
50.0%
2/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
32.0%
16/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
39.6%
19/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
47.6%
10/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
38.5%
50/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
32.0%
16/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
33.3%
16/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
23.8%
5/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
31.5%
41/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
24.0%
12/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
33.3%
16/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
19.0%
4/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
13.1%
17/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
50.0%
2/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
4/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.4%
5/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
21.5%
28/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
5/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
8.3%
4/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.3%
3/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
15.4%
20/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.0%
8/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
8.3%
4/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.5%
2/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
8.5%
11/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
5/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.0%
13/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Hemorrhoids
|
10.0%
5/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.2%
2/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
5.4%
7/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.5%
2/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
3.1%
4/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.3%
3/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Toothache
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
1/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.5%
2/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Fatigue
|
44.0%
22/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
52.1%
25/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
52.4%
11/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
53.8%
70/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
50.0%
2/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Asthenia
|
18.0%
9/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
18.8%
9/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
12.3%
16/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Pyrexia
|
10.0%
5/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
29.2%
14/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
23.8%
5/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
12.3%
16/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Mucosal inflammation
|
2.0%
1/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
8.3%
4/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
12.3%
16/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Odema peripheral
|
8.0%
4/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
16.7%
8/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.0%
13/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
50.0%
2/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Malaise
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
8.3%
4/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
23.8%
5/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
1.5%
2/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Urinary tract infection
|
12.0%
6/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
8.3%
4/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.3%
3/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
12.3%
16/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.0%
7/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.4%
5/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
13.8%
18/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Nasopharyngitis
|
14.0%
7/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.3%
3/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.0%
13/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Cystitis
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.2%
2/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.3%
3/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Cellulitis
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Herpes zoster
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.3%
3/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
8.3%
4/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
1.5%
2/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Pharyngitis
|
2.0%
1/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Neutrophil count decreased
|
32.0%
16/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
39.6%
19/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
61.9%
13/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
19.2%
25/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
White blood cell count decreased
|
28.0%
14/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
35.4%
17/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
61.9%
13/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
16.9%
22/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Platelet count decreased
|
22.0%
11/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
29.2%
14/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
33.3%
7/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
15.4%
20/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
18.0%
9/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.6%
7/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
23.8%
5/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.6%
19/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Alanine aminotransferase increased
|
16.0%
8/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.6%
7/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
23.8%
5/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.8%
14/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Lymphocyte count decreased
|
8.0%
4/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.6%
7/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.5%
2/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
12.3%
16/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Weight decreased
|
12.0%
6/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.6%
7/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
23.8%
5/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.9%
9/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Blood bilirubin increased
|
8.0%
4/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
23.8%
5/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
8.5%
11/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
12.5%
6/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
28.6%
6/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.9%
9/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
12.0%
6/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.3%
3/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
8.0%
4/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.3%
3/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.0%
1/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
12.5%
6/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
5.4%
7/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Troponin I increased
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Ejection fraction decreased
|
2.0%
1/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
1.5%
2/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
34.0%
17/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
45.8%
22/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
28.6%
6/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
33.1%
43/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
19.0%
4/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
11.5%
15/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.0%
1/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
19.0%
4/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.0%
2/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.3%
3/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.2%
2/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.3%
3/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
13.8%
18/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.0%
8/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
16.7%
8/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
12.3%
16/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
5/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.4%
5/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.0%
13/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.2%
12/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
8.3%
4/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.5%
2/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.9%
9/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.5%
2/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Headache
|
16.0%
8/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
27.1%
13/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.5%
2/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
24.6%
32/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
50.0%
2/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
5/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.6%
7/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
8/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.4%
5/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.5%
2/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.0%
13/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.5%
2/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
8/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Psychiatric disorders
Insomnia
|
12.0%
6/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.4%
5/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
23.8%
5/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
5.4%
7/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Psychiatric disorders
Anxiety
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.4%
5/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.5%
2/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.9%
9/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Psychiatric disorders
Dizziness
|
14.0%
7/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
12.5%
6/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.0%
13/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.3%
3/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.0%
13/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
22.9%
11/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
23.8%
5/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
26.2%
34/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.0%
6/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.1%
1/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.5%
2/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
18.5%
24/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.0%
8/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.4%
5/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
15.4%
20/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
12.0%
6/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.3%
3/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
5.4%
7/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
14.0%
7/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
19.0%
4/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.3%
3/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
25/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
60.4%
29/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
38.1%
8/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
47.7%
62/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
50.0%
2/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
5/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
16.7%
8/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
12.3%
16/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.0%
2/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.9%
9/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
2.0%
1/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
8/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.0%
2/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
9.5%
2/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
3.1%
4/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
8.3%
4/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
7.7%
10/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.6%
6/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
40.0%
20/50 • Number of events 51 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
43.8%
21/48 • Number of events 68 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
47.6%
10/21 • Number of events 30 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
30.0%
39/130 • Number of events 139 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Number of events 1 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Chills
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Influenza like illness
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
7.7%
10/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
COVID-19
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
8.3%
4/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
8/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Pneumonia
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
4.8%
1/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Investigations
Troponin increased
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
5/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.4%
5/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
19.0%
4/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
10.4%
5/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
19.0%
4/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
14.3%
3/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Psychiatric disorders
Depression
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Reproductive system and breast disorders
Breast pain
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Vascular disorders
Hot flush
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
1.5%
2/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Vascular disorders
Lymphoedema
|
6.0%
3/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
5.4%
7/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.2%
3/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
General disorders
Localised oedema
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
3.1%
4/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
1.5%
2/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Nervous system disorders
Brain fog
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
2.3%
3/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
6.9%
9/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
5.4%
7/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/50 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/48 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.00%
0/21 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
0.77%
1/130 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
25.0%
1/4 • Adverse event (AE) data were collected from Day 0 through Day 47 post last dose of study drug.
A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that occurred, having been absent before the first dose of study drug, or had worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
|
Additional Information
Contact for Clinical Trial Information
Daiichi Sankyo
Phone: 1-908-992-6400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place