Trial Outcomes & Findings for Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas (NCT NCT03532295)
NCT ID: NCT03532295
Last Updated: 2025-11-21
Results Overview
Overall survival is defined as the time interval from date of treatment start to date of a documented death event (death due to any cause) or date of censoring. If a patient has not had an event, OS will be censored at the date of last follow up.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
At 9 months
Results posted on
2025-11-21
Participant Flow
Participant milestones
| Measure |
Regimen A: Retifanlimab+RT+bevacizumab
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Treatment may continue for up to two years.
|
Regimen B: Retifanlimab+RT+bevacizumab+epacadostat
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Epacadostat will be administered orally at 400 mg BID.
* Treatment may continue for up to two years.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
27
|
|
Overall Study
COMPLETED
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Regimen A: Retifanlimab+RT+bevacizumab
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Treatment may continue for up to two years.
|
Regimen B: Retifanlimab+RT+bevacizumab+epacadostat
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Epacadostat will be administered orally at 400 mg BID.
* Treatment may continue for up to two years.
|
|---|---|---|
|
Overall Study
Did not start treatment
|
0
|
2
|
Baseline Characteristics
Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas
Baseline characteristics by cohort
| Measure |
Regimen A: Retifanlimab+RT+Bevacizumab
n=24 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Treatment may continue for up to two years.
|
Regimen B: Retifanlimab+RT+Bevacizumab+Epacadostat
n=27 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Epacadostat will be administered orally at 400 mg BID.
* Treatment may continue for up to two years.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=68 Participants
|
58 years
n=76 Participants
|
62 years
n=48 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=68 Participants
|
8 Participants
n=76 Participants
|
14 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=68 Participants
|
19 Participants
n=76 Participants
|
37 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=68 Participants
|
1 Participants
n=76 Participants
|
1 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=68 Participants
|
26 Participants
n=76 Participants
|
50 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=68 Participants
|
1 Participants
n=76 Participants
|
1 Participants
n=48 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=68 Participants
|
26 Participants
n=76 Participants
|
50 Participants
n=48 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=68 Participants
|
27 participants
n=76 Participants
|
51 participants
n=48 Participants
|
PRIMARY outcome
Timeframe: At 9 monthsOverall survival is defined as the time interval from date of treatment start to date of a documented death event (death due to any cause) or date of censoring. If a patient has not had an event, OS will be censored at the date of last follow up.
Outcome measures
| Measure |
Regimen A: Retifanlimab+RT+bevacizumab
n=24 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Treatment may continue for up to two years.
|
Regimen B: Retifanlimab+RT+bevacizumab+epacadostat
n=25 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Epacadostat will be administered orally at 400 mg BID.
* Treatment may continue for up to two years.
|
|---|---|---|
|
Kaplan-Meier Estimate of Overall Survival (OS) at 9 Months
|
67 percentage of participants-Kaplan Meier
Interval 50.0 to 82.0
|
67 percentage of participants-Kaplan Meier
Interval 51.0 to 89.0
|
PRIMARY outcome
Timeframe: At 12 monthsOverall survival is defined as the time interval from date of treatment start to date of a documented death event (death due to any cause) or date of censoring. If a patient has not had an event, OS will be censored at the date of last follow up.
Outcome measures
| Measure |
Regimen A: Retifanlimab+RT+bevacizumab
n=24 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Treatment may continue for up to two years.
|
Regimen B: Retifanlimab+RT+bevacizumab+epacadostat
n=25 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Epacadostat will be administered orally at 400 mg BID.
* Treatment may continue for up to two years.
|
|---|---|---|
|
Kaplan-Meier Estimate of Overall Survival (OS) at 12 Months
|
50 percentage of participants-Kaplan Meier
Interval 34.0 to 75.0
|
38 percentage of participants-Kaplan Meier
Interval 23.0 to 63.0
|
PRIMARY outcome
Timeframe: Through 2 years after completion of treatment (estimated to be 4 years)Overall survival is defined as the time interval from date of treatment start to date of a documented death event (death due to any cause) or date of censoring. If a patient has not had an event, OS will be censored at the date of last follow up.
Outcome measures
| Measure |
Regimen A: Retifanlimab+RT+bevacizumab
n=24 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Treatment may continue for up to two years.
|
Regimen B: Retifanlimab+RT+bevacizumab+epacadostat
n=25 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Epacadostat will be administered orally at 400 mg BID.
* Treatment may continue for up to two years.
|
|---|---|---|
|
Median Overall Survival (OS)
|
11.53 months
Interval 9.79 to 17.97
|
10.55 months
Interval 9.23 to 13.83
|
SECONDARY outcome
Timeframe: Screening (mean 9 days, range 1-21 days prior to treatment) & at last assessment (31/49 patients measured at end of treatment, 18 patients' last measurement was on Cycle 2-23 with a mean of 5.8 cycles)Population: Last assessment indicates the last time that a patient had an assessment of neurologic function measured via the NANO scale. Regimen A N=14 and Regimen B N=17 had the last assessment at end of treatment. Regimen A N=10 and Regimen B N=8 had the last assessment during treatment.
* There are 9 domains (gait, strength, ataxia, sensation, visual fields, facial strength, language, level of consciousness, and behavior). * Each domain is subdivided into 3 or 4 levels of function with scores based on discrete quantifiable measures. Each domain is scored from 0 to 3 points based on the severity of neurological deficit. A score of 0 indicates normal neurologic function, a score of 1 indicates mild impairment, 2 indicates severe impairment, and the highest score of 3 indicates the most severe level of deficit (incomplete hemianopsia) for that domain. Levels of function are distinguished by significant and measurable differences in order to avoid misinterpretation of subtle or nonspecific changes. * The total NANO score is the sum of the scores across all the 9 domains with a minimum score of 0 indicating normal function and a maximum score of 27 points indicating severe impairment. The total NANO score defines overall response criteria
Outcome measures
| Measure |
Regimen A: Retifanlimab+RT+bevacizumab
n=24 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Treatment may continue for up to two years.
|
Regimen B: Retifanlimab+RT+bevacizumab+epacadostat
n=25 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Epacadostat will be administered orally at 400 mg BID.
* Treatment may continue for up to two years.
|
|---|---|---|
|
Change in Neurologic Functions as Measured by the Neurologic Function in Neuro-Oncology (NANO) Scale
Screening
|
1.875 score on a scale
Standard Deviation 2.071
|
2.12 score on a scale
Standard Deviation 2.333
|
|
Change in Neurologic Functions as Measured by the Neurologic Function in Neuro-Oncology (NANO) Scale
Last assessment
|
2.952 score on a scale
Standard Deviation 2.906
|
3.273 score on a scale
Standard Deviation 2.865
|
SECONDARY outcome
Timeframe: 90 days after completion of treatment (estimated to be 2 years and 90 days)-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting
Outcome measures
| Measure |
Regimen A: Retifanlimab+RT+bevacizumab
n=24 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Treatment may continue for up to two years.
|
Regimen B: Retifanlimab+RT+bevacizumab+epacadostat
n=25 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Epacadostat will be administered orally at 400 mg BID.
* Treatment may continue for up to two years.
|
|---|---|---|
|
Safety and Toxicity of Regimen as Measured by Immune Related Grade 3 or Higher Adverse Events Experienced by Participant
Aspartate aminotransferase increased
|
0 Participants
|
1 Participants
|
|
Safety and Toxicity of Regimen as Measured by Immune Related Grade 3 or Higher Adverse Events Experienced by Participant
Seizure
|
4 Participants
|
5 Participants
|
|
Safety and Toxicity of Regimen as Measured by Immune Related Grade 3 or Higher Adverse Events Experienced by Participant
Colitis
|
1 Participants
|
0 Participants
|
|
Safety and Toxicity of Regimen as Measured by Immune Related Grade 3 or Higher Adverse Events Experienced by Participant
Diarrhea
|
2 Participants
|
0 Participants
|
|
Safety and Toxicity of Regimen as Measured by Immune Related Grade 3 or Higher Adverse Events Experienced by Participant
Vomiting
|
1 Participants
|
1 Participants
|
|
Safety and Toxicity of Regimen as Measured by Immune Related Grade 3 or Higher Adverse Events Experienced by Participant
Alanine aminotransferase increased
|
2 Participants
|
1 Participants
|
|
Safety and Toxicity of Regimen as Measured by Immune Related Grade 3 or Higher Adverse Events Experienced by Participant
Rash
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At 9 months* Duration of time from start of treatment to radiographic progression or death due to any cause, whichever occurs first * Radiographic progression will be assessed using the RECIST 1.1. If the disease recurrence/progression assessment involves more than one date, the earliest date will be used as the event date. A patient will be censored at the date of the last radiographic disease assessment indicating a lack of disease progression, if any of the following occurs before documented disease progression: alive and lack evidence of progression at the end of study or at the time of analysis data cut-off, disease progression or death occurs right after missing data for a scheduled radiographic disease assessment, patient receives non-protocol treatment, or equivocal findings of recurrence - treatment may continue until the next scheduled assessment. If recurrence is confirmed at the next scheduled assessment, the date of recurrence should be the earlier date when recurrence was suspected
Outcome measures
| Measure |
Regimen A: Retifanlimab+RT+bevacizumab
n=24 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Treatment may continue for up to two years.
|
Regimen B: Retifanlimab+RT+bevacizumab+epacadostat
n=25 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Epacadostat will be administered orally at 400 mg BID.
* Treatment may continue for up to two years.
|
|---|---|---|
|
Kaplan-Meier Estimate of Progression-Free Survival (PFS) at 9 Months
|
42 percentage of participants-Kaplan Meier
Interval 26.0 to 67.0
|
21 percentage of participants-Kaplan Meier
Interval 10.0 to 45.0
|
SECONDARY outcome
Timeframe: At 12 months* Duration of time from start of treatment to radiographic progression or death due to any cause, whichever occurs first * Radiographic progression will be assessed using the RECIST 1.1. If the disease recurrence/progression assessment involves more than one date, the earliest date will be used as the event date. A patient will be censored at the date of the last radiographic disease assessment indicating a lack of disease progression, if any of the following occurs before documented disease progression: alive and lack evidence of progression at the end of study or at the time of analysis data cut-off, disease progression or death occurs right after missing data for a scheduled radiographic disease assessment, patient receives non-protocol treatment, or equivocal findings of recurrence - treatment may continue until the next scheduled assessment. If recurrence is confirmed at the next scheduled assessment, the date of recurrence should be the earlier date when recurrence was suspected
Outcome measures
| Measure |
Regimen A: Retifanlimab+RT+bevacizumab
n=24 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Treatment may continue for up to two years.
|
Regimen B: Retifanlimab+RT+bevacizumab+epacadostat
n=25 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Epacadostat will be administered orally at 400 mg BID.
* Treatment may continue for up to two years.
|
|---|---|---|
|
Kaplan-Meier Estimate of Progression-Free Survival (PFS) at 12 Months
|
25 percentage of participants-Kaplan Meier
Interval 13.0 to 50.0
|
4 percentage of participants-Kaplan Meier
Interval 1.0 to 28.0
|
SECONDARY outcome
Timeframe: Through 2 years after completion of treatment (estimated to be 4 years)* Duration of time from start of treatment to radiographic progression or death due to any cause, whichever occurs first * Radiographic progression will be assessed using the RECIST 1.1. If the disease recurrence/progression assessment involves more than one date, the earliest date will be used as the event date. A patient will be censored at the date of the last radiographic disease assessment indicating a lack of disease progression, if any of the following occurs before documented disease progression: alive and lack evidence of progression at the end of study or at the time of analysis data cut-off, disease progression or death occurs right after missing data for a scheduled radiographic disease assessment, patient receives non-protocol treatment, or equivocal findings of recurrence - treatment may continue until the next scheduled assessment. If recurrence is confirmed at the next scheduled assessment, the date of recurrence should be the earlier date when recurrence was suspected
Outcome measures
| Measure |
Regimen A: Retifanlimab+RT+bevacizumab
n=24 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Treatment may continue for up to two years.
|
Regimen B: Retifanlimab+RT+bevacizumab+epacadostat
n=25 Participants
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Epacadostat will be administered orally at 400 mg BID.
* Treatment may continue for up to two years.
|
|---|---|---|
|
Median Progression-Free Survival (PFS)
|
6.98 months
Interval 5.55 to 11.04
|
7.20 months
Interval 5.78 to 8.61
|
Adverse Events
Regimen A: Retifanlimab+RT+bevacizumab
Serious events: 11 serious events
Other events: 24 other events
Deaths: 24 deaths
Regimen B: Retifanlimab+RT+bevacizumab+epacadostat
Serious events: 16 serious events
Other events: 25 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Regimen A: Retifanlimab+RT+bevacizumab
n=24 participants at risk
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Treatment may continue for up to two years.
|
Regimen B: Retifanlimab+RT+bevacizumab+epacadostat
n=25 participants at risk
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Epacadostat will be administered orally at 400 mg BID.
* Treatment may continue for up to two years.
|
|---|---|---|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Muscle weakness right-sided
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Seizure
|
16.7%
4/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
20.0%
5/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Stroke
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Syncope
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Psychiatric disorders
Agitation
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Psychiatric disorders
Confusion
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
12.0%
3/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Dysphagia
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Death NOS
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Fatigue
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Gait disturbance
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Ehrlichhiosis
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Lung infection
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Urinary tract infection
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Wound infection
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Alanine aminotransferase increased
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
BUN increased
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Platelet count decreased
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Weight loss
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Anorexia
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to disease progression
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Akathisia
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Dysphasia
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Colitis
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
Other adverse events
| Measure |
Regimen A: Retifanlimab+RT+bevacizumab
n=24 participants at risk
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Treatment may continue for up to two years.
|
Regimen B: Retifanlimab+RT+bevacizumab+epacadostat
n=25 participants at risk
* Retifanlimab will be given intravenously over the course of 30 to 60 minutes at a dose of 500 mg on Day 1 of each 28-day cycle.
* Bevacizumab will be given intravenously at a dose of 10 mg/kg on Days 1 and 15 of each 28-day cycle.
* Ten fractions of radiation therapy will be given at a dose of 3.5 Gy per fraction
* Retifanlimab and bevacizumab will be started approximately two weeks before the first day of radiation therapy
* Epacadostat will be administered orally at 400 mg BID.
* Treatment may continue for up to two years.
|
|---|---|---|
|
Eye disorders
Double vision
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Blood and lymphatic system disorders
Anemia
|
20.8%
5/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
48.0%
12/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Blood and lymphatic system disorders
Gum bleeding
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Cardiac disorders
Atrial fibrillation
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Cardiac disorders
Chest pain - cardiac
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Cardiac disorders
Sinus bradycardia
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Ear and labyrinth disorders
Hearing impaired
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Endocrine disorders
Adrenal insufficiency
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Endocrine disorders
Hyperthyroidism
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Endocrine disorders
Hypothyroidism
|
12.5%
3/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
24.0%
6/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Eye disorders
Blurred vision
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Eye disorders
Dry eye
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Eye disorders
Eye pain
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Eye disorders
Eye stye
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Eye disorders
Left homonymous hemianopsia
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Eye disorders
Right homonymous hemianopsia
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Eye disorders
Vision cut
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Eye disorders
Vision decreased
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Constipation
|
25.0%
6/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
28.0%
7/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
6/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
52.0%
13/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Dyspepsia
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
12.0%
3/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Dysphagia
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Fecal incontinence
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Mouth sore
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Nausea
|
29.2%
7/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
48.0%
12/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Stomach pain
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
4/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
32.0%
8/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Chills
|
12.5%
3/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Drooling
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Edema face
|
12.5%
3/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Edema limbs
|
12.5%
3/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Facial pain
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Fatigue
|
58.3%
14/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
60.0%
15/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Fever
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
24.0%
6/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Flu like symptoms
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
12.0%
3/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Gait disturbance
|
12.5%
3/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Generalized edema
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Malaise
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Non-cardiac chest pain
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Pain
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
12.0%
3/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Pain (fingers)
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Pain (foot)
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Pain (intermittent shooting pain)
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Pain (left hand pain)
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Pain (left hip, calf, and foot)
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
General disorders
Pain (shoulder)
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Bone infection
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
COVID-19 infection
|
12.5%
3/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
12.0%
3/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Enterocolitis infection
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Lip infection
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Otitis externa
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Rash pustular
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Skin infection
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Thrush
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Upper respiratory infection
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Urinary tract infection
|
16.7%
4/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Infections and infestations
Yeast infection on stomach
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Injury, poisoning and procedural complications
Bruising
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Injury, poisoning and procedural complications
Fall
|
20.8%
5/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
20.0%
5/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Injury, poisoning and procedural complications
Fracture
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Injury, poisoning and procedural complications
Wound complication
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Alanine aminotransferase increased
|
37.5%
9/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
32.0%
8/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Alkaline phosphatase increased
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
6/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
16.0%
4/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
BUN increased
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Blood bilirubin increased
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Cholesterol high
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Creatinine increased
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
32.0%
8/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Decreased blood protein
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Hemoglobin increased
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Lipase increased
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Lymphocyte count decreased
|
62.5%
15/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
60.0%
15/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Monocytes increased
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Neutrophil count decreased
|
16.7%
4/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
16.0%
4/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Neutrophil count increased
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Platelet count decreased
|
41.7%
10/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
36.0%
9/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
T4 increased
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Thyroid stimulating hormone increased
|
25.0%
6/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
12.0%
3/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Weight gain
|
20.8%
5/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
16.0%
4/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
Weight loss
|
37.5%
9/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
40.0%
10/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
White blood cell count increased
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Investigations
White blood cell decreased
|
41.7%
10/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
24.0%
6/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Anorexia
|
20.8%
5/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
36.0%
9/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
12.5%
3/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
12.0%
3/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
4/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
20.0%
5/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
8/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
16.0%
4/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
3/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
12.0%
3/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
8/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
28.0%
7/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.8%
5/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
3/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
50.0%
12/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Musculoskeletal and connective tissue disorders
Leg and knee pain
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cysts
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue lesion
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Amnesia
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Aphasia
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Cognitive disturbance
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
16.0%
4/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Dizziness
|
12.5%
3/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
20.0%
5/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Dysarthria
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Dysgeusia
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Dysphasia
|
20.8%
5/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Facial muscle weakness
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Headache
|
25.0%
6/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
52.0%
13/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Hemineglect
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Left side neglect
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Memory impairment
|
12.5%
3/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
12.0%
3/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
20.0%
5/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Muscle weakness right-sided
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Occipital seizure
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Paresthesia
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Phantom smells
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Seizure
|
16.7%
4/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
12.0%
3/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Short-term memory loss
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Sour taste
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Spasticity
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Spinal stenosis
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Stroke
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Syncope
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Tremor
|
12.5%
3/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Nervous system disorders
Word finding difficulties
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Psychiatric disorders
Agitation
|
12.5%
3/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Psychiatric disorders
Anxiety
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Psychiatric disorders
Blunted affect
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Psychiatric disorders
Confusion
|
29.2%
7/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
28.0%
7/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Psychiatric disorders
Depression
|
12.5%
3/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
12.0%
3/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
12.0%
3/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Psychiatric disorders
Insomnia
|
20.8%
5/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
12.0%
3/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Psychiatric disorders
Irritability
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Renal and urinary disorders
Glucosuria
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Renal and urinary disorders
Hematuria
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
16.0%
4/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Renal and urinary disorders
Overactive bladder
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Renal and urinary disorders
Proteinuria
|
54.2%
13/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
56.0%
14/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Reproductive system and breast disorders
Amenorrhea
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
6/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.8%
5/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
12.0%
3/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
3/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
12.0%
3/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Chafing
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Facial cyst
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity reaction
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Malar rash
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
4/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
8.0%
2/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
44.0%
11/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Redness, small patch on right shoulder
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Seborrheic dermatitis
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Vascular disorders
Flushing
|
4.2%
1/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Vascular disorders
Hypertension
|
70.8%
17/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
64.0%
16/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Vascular disorders
Hypotension
|
0.00%
0/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
4.0%
1/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
|
Vascular disorders
Thromboembolic event
|
8.3%
2/24 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
0.00%
0/25 • Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).
|
Additional Information
Dr. Milan Chheda
Washington University School of Medicine
Phone: 314-747-7222
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place