Trial Outcomes & Findings for Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma (NCT NCT00073749)
NCT ID: NCT00073749
Last Updated: 2018-12-17
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAE) are defined as any new event reported after first dose of study drug up to 42 days after last dose of study drug, or any event that is worse in severity than at any time during the baseline period. AEs included both SAEs and non-serious adverse events (non-SAEs).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
79 participants
Primary outcome timeframe
Baseline up to 42 days after last dose of study drug (up to Day 225)
Results posted on
2018-12-17
Participant Flow
The study was conducted in 2 parts. Part 1: Dose escalation cohorts of inotuzumab ozogamicin to determine the maximum tolerated dose (MTD) included 21 days and 28 days dose administration cycles. Part 2: Expanded cohort using the MTD regimen identified in Part 1.
Participant milestones
| Measure |
Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1
Participants with CD22-positive B-cell non-Hodgkin lymphoma (NHL) received 0.4 milligrams per square meter (mg/m\^2) intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2
Participants with CD22-positive B-cell NHL received 0.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in Cohort
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Expanded Cohort
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
5
|
11
|
6
|
6
|
6
|
43
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
11
|
6
|
6
|
6
|
40
|
Reasons for withdrawal
| Measure |
Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1
Participants with CD22-positive B-cell non-Hodgkin lymphoma (NHL) received 0.4 milligrams per square meter (mg/m\^2) intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2
Participants with CD22-positive B-cell NHL received 0.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in Cohort
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Expanded Cohort
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Disease Progression
|
2
|
0
|
3
|
2
|
3
|
1
|
3
|
|
Overall Study
Death
|
0
|
1
|
1
|
0
|
0
|
0
|
29
|
|
Overall Study
Adverse Event
|
0
|
3
|
6
|
4
|
2
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
1
|
0
|
2
|
|
Overall Study
Discontinuation of Study by Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Study Evaluating CMC-544 In B-Cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1
n=2 Participants
Participants with CD22-positive B-cell non-Hodgkin lymphoma (NHL) received 0.4 milligrams per square meter (mg/m\^2) intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2
n=5 Participants
Participants with CD22-positive B-cell NHL received 0.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
n=11 Participants
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
n=6 Participants
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
n=6 Participants
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in Cohort
n=6 Participants
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Expanded Cohort
n=43 Participants
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
50.50 years
STANDARD_DEVIATION 13.44 • n=5 Participants
|
73.80 years
STANDARD_DEVIATION 2.59 • n=7 Participants
|
65.45 years
STANDARD_DEVIATION 10.56 • n=5 Participants
|
56.67 years
STANDARD_DEVIATION 5.96 • n=4 Participants
|
60.00 years
STANDARD_DEVIATION 12.82 • n=21 Participants
|
57.17 years
STANDARD_DEVIATION 12.25 • n=8 Participants
|
57.30 years
STANDARD_DEVIATION 10.91 • n=8 Participants
|
59.46 years
STANDARD_DEVIATION 11.29 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
32 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
47 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 42 days after last dose of study drug (up to Day 225)Population: Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAE) are defined as any new event reported after first dose of study drug up to 42 days after last dose of study drug, or any event that is worse in severity than at any time during the baseline period. AEs included both SAEs and non-serious adverse events (non-SAEs).
Outcome measures
| Measure |
Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5
n=30 Participants
Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m\^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
n=49 Participants
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
29 participants
|
49 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
11 participants
|
15 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 42 days after last dose of study drug (up to Day 225)Population: Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin.
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE severity was defined to be the maximum toxicity grade of the treatment-emergent adverse events (TEAEs) experienced by the participants during the study. AE was assessed according to severity; Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening or disabling AE), Grade 5 (death related to AE). Participants with Grade 3 or higher grades TEAEs were reported.
Outcome measures
| Measure |
Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5
n=30 Participants
Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m\^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
n=49 Participants
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 or Higher Grades Treatment-Emergent Adverse Events (TEAEs) Based on Severity
|
24 participants
|
42 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 28Population: Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin. This outcome measure was not planned to be analyzed in Part 2 of the study.
MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced dose limiting toxicity (DLT). DLT was defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to \[\>=\] 7 days), delayed recovery (less than or equal to \[\<=\] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 2 weeks.
Outcome measures
| Measure |
Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5
n=30 Participants
Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m\^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD): Part 1 (Dose Escalation Cohorts)
|
1.8 milligram per meter square (mg/m^2)
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Day 28Population: Safety population included all participants who received at least 1 dose of inotuzumab ozogamicin. Here number of participant analyzed (N) signifies participants evaluable for this outcome measure.
DLT was classified as per National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 3.0 and defined as any of the following events occurring during the first 21 days (or 28 days for participants treated every 4 weeks) days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 non-hematologic toxicity except grade 3 alopecia, nausea, or vomiting, any grade 4 febrile neutropenia, any grade 4 thrombocytopenia or any bleeding episode requiring platelet transfusion, any grade 4 absolute neutrophil count (for a duration of greater than or equal to \[\>=\] 7 days), delayed recovery (less than or equal to \[\<=\] grade 1 or baseline) from a toxicity that delays the initiation of the next dose by more than 14 days.
Outcome measures
| Measure |
Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5
n=2 Participants
Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m\^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
n=5 Participants
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
n=11 Participants
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
n=6 Participants
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
n=6 Participants
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
n=6 Participants
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicity (DLT)
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)Population: Evaluable population: All participants who received at least 2 doses of study drug, had baseline tumor computed tomography (CT) scan, and at least 1 post-baseline tumor assessment for anti-cancer clinical activity. Here 'N' represents number of participants evaluable for this outcome measure. This was not planned to be analyzed in Part 1 of study.
PFS was based on Kaplan-Meier estimates. PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per the International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
Outcome measures
| Measure |
Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5
n=35 Participants
Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m\^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)
With Diffuse Lymphoma
|
103 days
Interval 52.0 to 135.0
|
—
|
—
|
—
|
—
|
—
|
|
Progression-Free Survival (PFS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)
With Follicular Lymphoma
|
311 days
Interval 211.0 to 569.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)Population: Intent-to-treat (ITT) population included all enrolled participants. Here 'N' represents number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study.
PFS was based on Kaplan-Meier estimates. PFS was defined as the time interval from the first dose of study medication until the first date on which relapsed disease, or progression (as per International Response Criteria for Non-Hodgkin Lymphoma) or death, was documented, censored at the last tumor evaluation date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
Outcome measures
| Measure |
Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5
n=48 Participants
Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m\^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS): Intent-to-treat Population-Part 2 (Lead-in + Expanded Cohorts)
With Diffuse Lymphoma
|
49.5 days
Interval 29.0 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Progression-Free Survival (PFS): Intent-to-treat Population-Part 2 (Lead-in + Expanded Cohorts)
With Follicular Lymphoma
|
254 days
Interval 182.0 to 386.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Year 5Population: Evaluable population: All participants who received at least 2 doses of study drug, had baseline tumor CT scan, and at least 1 post-baseline tumor assessment for anti-cancer clinical activity. Here 'N' represents number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of study.
OS was based on Kaplan-Meier method. Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
Outcome measures
| Measure |
Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5
n=35 Participants
Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m\^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)
With Diffuse Lymphoma
|
274 days
Interval 169.0 to 519.0
|
—
|
—
|
—
|
—
|
—
|
|
Overall Survival (OS): Evaluable Population- Part 2 (Lead-in + Expanded Cohorts)
With Follicular Lymphoma
|
NA days
Data not collected since median overall survival was not reached for the participants with follicular lymphoma.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Year 5Population: ITT population included all enrolled participants. Here 'N' signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study.
Interval OS was based on Kaplan-Meier method. Survival was defined as the time period from the first dose of study drug until the date of death, censored at the participant's last contact date. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
Outcome measures
| Measure |
Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5
n=48 Participants
Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m\^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS): Intent-to-treat Population: Part 2 (Lead-in + Expanded Cohorts)
With Diffuse Lymphoma
|
194 days
Interval 128.0 to 363.0
|
—
|
—
|
—
|
—
|
—
|
|
Overall Survival (OS): Intent-to-treat Population: Part 2 (Lead-in + Expanded Cohorts)
With Follicular Lymphoma
|
1147 days
Interval 523.0 to
Data not collected since upper limit for overall survival was not reached for participants with follicular lymphoma.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)Population: Evaluable population was analyzed. Participants with diffuse or follicular lymphoma were analyzed. This outcome measure was not planned to be analyzed in Part 1 and Part 2 (Lead-in Cohort).
Participants with BOR=with complete response(CR),unconfirmed CR(CRu) or partial response (PR) as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical,radiographic sign of disease/related symptoms,normalization biochemical abnormalities related to NHL;if enlarged before therapy all lymph nodes,nodal masses,other organs regressed to normal size and spleen regressed in size,undetectable on physical exam,clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass \>1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by \>75% in product diameters and indeterminate bone marrow. PR:\>=50% decrease in sum of products of greatest diameters(SPD) of 6 largest dominant nodes/nodal masses,no increase in size of other nodes/spleen/liver, 50% decrease in SPD of splenic,hepatic nodules,involvement of other organs considered assessable,not measurable disease with exception of splenic,hepatic nodules.
Outcome measures
| Measure |
Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5
n=30 Participants
Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m\^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts)
CR: With Follicular Lymphoma
|
1 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts)
CR: With Diffuse Lymphoma
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts)
CRu: With Follicular Lymphoma
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts)
CRu: With Diffuse Lymphoma
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts)
PR: With Follicular Lymphoma
|
8 participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Best Overall Response (BOR): Part 2 (Expanded Cohorts)
PR: With Diffuse Lymphoma
|
5 participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)Population: Evaluable population was analyzed. DoR included evaluable participants who achieved CR, CRu, or PR. Here 'N' signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study.
Duration of overall response was defined as the time from the date that measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the first date that relapsed disease was objectively documented as per International Response Criteria for NHL, taking as reference for relapsed disease the smallest measurements recorded since the treatment started. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
Outcome measures
| Measure |
Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5
n=22 Participants
Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m\^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|
|
Duration of Overall Response (DoR): Part 2 (Lead-in + Expanded Cohorts)
With Diffuse Lymphoma
|
80.00 days
Interval 42.0 to 1637.0
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Overall Response (DoR): Part 2 (Lead-in + Expanded Cohorts)
With Follicular Lymphoma
|
233.0 days
Interval 130.0 to 520.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)Population: Evaluable population was analyzed. Here "N" signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 and Part 2 (Lead-in Cohort) of the study.
Time to tumor progression was defined as the interval from the start of the treatment until the first date on which relapsed disease or progression is documented, censored at the last disease assessment. This outcome measure was analyzed in participants with follicular lymphoma or diffuse large B-cell lymphoma.
Outcome measures
| Measure |
Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5
n=30 Participants
Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m\^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|
|
Time-to-Tumor Progression: Part 2 (Expanded Cohorts)
With Diffuse Lymphoma
|
105 days
Interval 55.0 to
Data not collected since upper limit for time to tumor progression was not reached.
|
—
|
—
|
—
|
—
|
—
|
|
Time-to-Tumor Progression: Part 2 (Expanded Cohorts)
With Follicular Lymphoma
|
339 days
Interval 189.0 to
Data not collected since upper limit for time to tumor progression was not reached.
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 42 days after last dose (Day 225)Population: Evaluable population: All participants who received at least 2 doses of study drug, had baseline tumor CT scan, and at least 1 post-baseline tumor assessment for anti-cancer clinical activity. Here 'N' represents number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of study.
Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass \>1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by \>75% in product diameters and indeterminate bone marrow. PR: \>=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.
Outcome measures
| Measure |
Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5
n=35 Participants
Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m\^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response- Evaluable Population: Part 2 (Lead-in + Expanded Cohorts)
With Diffuse Lymphoma
|
25 percentage of participants
Interval 7.27 to 52.38
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Objective Response- Evaluable Population: Part 2 (Lead-in + Expanded Cohorts)
With Follicular Lymphoma
|
73.68 percentage of participants
Interval 48.8 to 90.85
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 42 days after last dose of study drug (Day 225)Population: ITT population included all enrolled participants. Here 'N' signifies number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 of the study.
Participants (having follicular or diffuse lymphoma) with objective response based assessment of CR, CRu or PR as per International Response Criteria for NHL. CR: Total disappearance of all detectable clinical, radiographic sign of disease/related symptoms, normalization biochemical abnormalities related to NHL; if enlarged before therapy all lymph nodes, nodal masses, other organs regressed to normal size and spleen regressed in size, undetectable on physical exam, clear bone marrow infiltrate. CRu: CR but allows for residual lymph node mass \>1.5 cm in greatest transverse diameter and all individual nodes previously merged were regressed by \>75% in product diameters and indeterminate bone marrow. PR: \>=50% decrease in SPD of 6 largest dominant nodes or nodal masses, no increase in size of other nodes, spleen or liver, 50% decrease in SPD of splenic, hepatic nodules, involvement of other organs considered assessable, not measurable disease with exception of splenic, hepatic nodules.
Outcome measures
| Measure |
Inotuzumab Ozogamicin: Dose Escalation Cohorts 1 to 5
n=48 Participants
Participants with CD22-positive B-cell NHL received 0.4 or 0.8 or 1.34 or 1.8 or 2.4 mg/m\^2 intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in + Expanded Cohorts
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response- Intent-to-treat Population: Part 2 (Lead in+ Expanded Cohorts)
With Diffuse Lymphoma
|
15.38 percentage of particpants
Interval 4.36 to 34.87
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Objective Response- Intent-to-treat Population: Part 2 (Lead in+ Expanded Cohorts)
With Follicular Lymphoma
|
68.12 percentage of particpants
Interval 45.13 to 86.14
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in Cohort
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Inotuzumab Ozogamicin 1.8 mg/m^2: Expanded Cohort
Serious events: 15 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1
n=2 participants at risk
Participants with CD22-positive B-cell non-Hodgkin lymphoma (NHL) received 0.4 milligrams per square meter (mg/m\^2) intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2
n=5 participants at risk
Participants with CD22-positive B-cell NHL received 0.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
n=11 participants at risk
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
n=6 participants at risk
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
n=6 participants at risk
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in Cohort
n=6 participants at risk
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Expanded Cohort
n=43 participants at risk
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|---|
|
General disorders
FEVER
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
3/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
ASTHENIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
ASCITES
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
SEPSIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
BACK PAIN
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
CELLULITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
CHILLS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
DEATH
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
HERNIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
MALAISE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
NEUTROPENIC FEVER
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
PAIN
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
SYNCOPE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
LIVER FUNCTION TESTS ABNORMAL
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
ANOREXIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
DIARRHEA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
VENOOCCLUSIVE LIVER DISEASE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
3/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
LYMPHOMA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
BILIRUBINEMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
LACTIC DEHYDROGENASE INCREASED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
MENTAL STATUS CHANGES
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
NEUROPATHY
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
ACUTE KIDNEY FAILURE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Inotuzumab Ozogamicin 0.4 mg/m^2: Dose Escalation Cohort 1
n=2 participants at risk
Participants with CD22-positive B-cell non-Hodgkin lymphoma (NHL) received 0.4 milligrams per square meter (mg/m\^2) intravenous (IV) dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 0.8 mg/m^2: Dose Escalation Cohort 2
n=5 participants at risk
Participants with CD22-positive B-cell NHL received 0.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was an evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.34 mg/m^2: Dose Escalation Cohort 3
n=11 participants at risk
Participants with CD22-positive B-cell NHL received 1.34 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Dose Escalation Cohort 4
n=6 participants at risk
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 2.4 mg/m^2: Dose Escalation Cohort 5
n=6 participants at risk
Participants with CD22-positive B-cell NHL received 2.4 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 21 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Lead-in Cohort
n=6 participants at risk
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
Inotuzumab Ozogamicin 1.8 mg/m^2: Expanded Cohort
n=43 participants at risk
Participants with CD22-positive B-cell NHL received 1.8 mg/m\^2 IV dose of inotuzumab ozogamicin on Day 1 of each cycle, for at least 4 cycles, unless there was evidence of disease progression or unacceptable toxicity. Each cycle was of 28 days.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
PHLEBITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
ASTHENIA
|
50.0%
1/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
80.0%
4/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
63.6%
7/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
66.7%
4/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
69.8%
30/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
HEMORRHAGE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
HYPOTENSION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
EXTRASYSTOLES
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
HYPERTENSION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
VASODILATATION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
MIGRAINE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
MYOCARDIAL ISCHEMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
PALLOR
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
PERIPHERAL VASCULAR DISORDER
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
POSTURAL HYPOTENSION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
SHOCK
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
SUPRAVENTRICULAR EXTRASYSTOLES
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
SYNCOPE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
VASCULAR ANOMALY
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
VASCULAR DISORDER
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
VASCULITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
NAUSEA
|
50.0%
1/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
60.0%
3/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
54.5%
6/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
66.7%
4/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
66.7%
4/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
46.5%
20/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
ANOREXIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.9%
12/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
23.3%
10/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
DIARRHEA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
18.6%
8/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
23.3%
10/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
GAMMA GLUTAMYL TRANSPEPTIDASE INCREASED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.3%
4/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
14.0%
6/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
3/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
LIVER FUNCTION TESTS ABNORMAL
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
ERUCTATION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
GASTROENTERITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
GUM HEMORRHAGE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
MUCOSITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
BLOOD IN STOOL
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
CHOLELITHIASIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
FECAL INCONTINENCE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
HEPATOMEGALY
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
LIVER FATTY DEPOSIT
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
NAUSEA AND VOMITING
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
ORAL MONILIASIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
PANCREAS DISORDER
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
RECTAL DISORDER
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
RECTAL HEMORRHAGE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
60.0%
3/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
72.7%
8/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
100.0%
6/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
83.3%
5/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
100.0%
6/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
88.4%
38/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
66.7%
4/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
48.8%
21/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.9%
12/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.9%
12/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
14.0%
6/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
ECCHYMOSIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
3/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
FIBRINOGEN INCREASED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
GRANULOCYTOSIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
LYMPHOMA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
THROMBIN TIME PROLONGED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
LYMPHOCYTOSIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
MEGAKARYOCYTES DECREASED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
PETECHIAE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
PURPURA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
RETICULOENDOTHELIAL HYPERPLASIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
SPLENOMEGALY
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
SGOT INCREASED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
45.5%
5/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
66.7%
4/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
41.9%
18/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
ALKALINE PHOSPHATASE INCREASED
|
50.0%
1/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
36.4%
4/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
25.6%
11/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
SGPT INCREASED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
36.4%
4/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
18.6%
8/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
BILIRUBINEMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
25.6%
11/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
PERIPHERAL EDEMA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
23.3%
10/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
14.0%
6/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
LACTIC DEHYDROGENASE INCREASED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
36.4%
4/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.3%
4/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
HYPOPROTEINEMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
14.0%
6/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
WEIGHT LOSS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
3/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
3/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.3%
4/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.3%
4/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
CREATININE INCREASED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
3/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
EDEMA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEREMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
BUN INCREASED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
HYPERCHLOREMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
HYPERLIPEMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
HYPOCHLOREMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
WEIGHT GAIN
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
50.0%
1/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
14.0%
6/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
MYASTHENIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
JOINT DISORDER
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE ATROPHY
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE CRAMP
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
TENDON DISORDER
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
11.6%
5/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
PARESTHESIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.3%
4/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
INSOMNIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
3/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
ANXIETY
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.3%
4/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
DEPRESSION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
NEUROPATHY
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
NERVOUSNESS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
AGITATION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
APHASIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
ATAXIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
CLONUS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
FACIAL PARALYSIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
HYPESTHESIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
MENTAL STATUS CHANGES
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
MYELOPATHY
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
NEUROPATHIC PAIN
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH INCREASED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
66.7%
4/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.3%
7/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
14.0%
6/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
14.0%
6/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.3%
7/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.3%
4/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
SINUSITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
3/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY INFECTION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.3%
4/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY PHYSICAL FINDING
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
HEMOPTYSIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUP
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
VOICE ALTERATION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
ALVEOLITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION NOS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL DISORDER
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
SPUTUM INCREASED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
THROAT IRRITATION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
3/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
SWEATING
|
50.0%
1/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
3/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
3/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
3/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
HERPES SIMPLEX
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
HERPES ZOSTER
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
FOLLICULITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
FUNGAL DERMATITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
PRURITIC RASH
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
SKIN BENIGN NEOPLASM
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
SKIN DISCOLORATION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
3/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
ALBUMINURIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
BREAST PAIN
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
CYSTITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
HEMATURIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
OLIGURIA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
TESTIS DISORDER
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
URINARY HESITATION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
URINE ABNORMALITY
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
FEVER
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
66.7%
4/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
39.5%
17/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
ABDOMINAL PAIN
|
50.0%
1/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
45.5%
5/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
66.7%
4/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
32.6%
14/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
HEADACHE
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
36.4%
4/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.9%
9/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
BACK PAIN
|
50.0%
1/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
45.5%
5/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.3%
4/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
PAIN
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.3%
7/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
CHILLS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
14.0%
6/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
LAB TEST ABNORMAL
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
7.0%
3/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
CHEST PAIN
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
11.6%
5/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
INFECTION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
ABDOMEN ENLARGED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
ACCIDENTAL INJURY
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
FLU SYNDROME
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
NECK PAIN
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
ASCITES
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
PELVIC PAIN
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
ALLERGIC REACTION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
FACE EDEMA
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
IMMUNOGLOBULINS DECREASED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
INJECTION SITE REACTION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
NEOPLASM
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
General disorders
RADIATION INJURY
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
ABNORMAL VISION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
EYE DISORDER
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
DRY EYES
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
CATARACT SPECIFIED
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
CORNEAL LESION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
EYE PAIN
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Investigations
TASTE PERVERSION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
4.7%
2/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Investigations
EAR PAIN
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Investigations
BLEPHARITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Investigations
EAR DISORDER
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Investigations
KERATITIS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Investigations
TASTE LOSS
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Investigations
REACTION UNEVALUABLE
|
50.0%
1/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Investigations
ALLERGIC REACTION OTHER THAN DRUG
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
2.3%
1/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
|
Investigations
DEVICE MALFUNCTION
|
0.00%
0/2 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
0.00%
0/43 • Treatment-emergent events: Baseline up to 42 days after last dose of study drug (up to Day 225)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER