Trial Outcomes & Findings for M6620 and Carboplatin With or Without Docetaxel in Treating Patients With Metastatic Castration-Resistant Prostate Cancer (NCT NCT03517969)
NCT ID: NCT03517969
Last Updated: 2025-10-20
Results Overview
Defined by radiographic response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or prostate specific antigen \[PSA\] response (\> 50% decline from baseline).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
Radiologic measurements are performed every 3 cycles Up to 2 years. PSA measurements are performed every cycle up to 2 years
Results posted on
2025-10-20
Participant Flow
77 subjects were registered, of whom, 73 subjects underwent randomization; 4 subjects did not undergo randomization: 1. Screen failure (n=3) 2. Patient withdrew to pursue other treatment option (n=1) Patient recruitment was terminated after interim analysis showing insufficient benefit in the investigational treatment group.
Participant milestones
| Measure |
Arm A (Docetaxel, Carboplatin)
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes, or carboplatin alone on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who have PSA progression or radiographic progression may crossover to Arm B.
|
Arm B (Carboplatin, Berzosertib)
Patients receive carboplatin IV over 30 minutes on day 1 and berzosertib IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
36
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
37
|
36
|
Reasons for withdrawal
| Measure |
Arm A (Docetaxel, Carboplatin)
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes, or carboplatin alone on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who have PSA progression or radiographic progression may crossover to Arm B.
|
Arm B (Carboplatin, Berzosertib)
Patients receive carboplatin IV over 30 minutes on day 1 and berzosertib IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Never started protocol treatment
|
3
|
5
|
|
Overall Study
Disease progression
|
11
|
16
|
|
Overall Study
PSA progression
|
8
|
1
|
|
Overall Study
Clinical progression
|
4
|
2
|
|
Overall Study
Adverse Event
|
5
|
4
|
|
Overall Study
Intercurrent illness
|
1
|
2
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
No clinical benefit
|
1
|
0
|
|
Overall Study
Delayed treatment for dental treatment
|
1
|
0
|
|
Overall Study
Difficult to maintain appointment
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
The analysis population included the 65 subjects who received the protocol treatment: 34 in Arm A and 31 in Arm B.
Baseline characteristics by cohort
| Measure |
Arm A (Docetaxel, Carboplatin)
n=34 Participants
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes, or carboplatin alone on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who have PSA progression or radiographic progression may crossover to Arm B.
|
Arm B (Carboplatin, Berzosertib)
n=31 Participants
Patients receive carboplatin IV over 30 minutes on day 1 and berzosertib IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 Years
n=5 Participants • The analysis population included the 65 subjects who received the protocol treatment: 34 in Arm A and 31 in Arm B.
|
69 Years
n=7 Participants • The analysis population included the 65 subjects who received the protocol treatment: 34 in Arm A and 31 in Arm B.
|
69 Years
n=5 Participants • The analysis population included the 65 subjects who received the protocol treatment: 34 in Arm A and 31 in Arm B.
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Baseline Prostate-Specific Antigen (PSA)
|
90 ng/mL
n=5 Participants
|
75 ng/mL
n=7 Participants
|
85 ng/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: Radiologic measurements are performed every 3 cycles Up to 2 years. PSA measurements are performed every cycle up to 2 yearsPopulation: The analysis population included the 65 subjects who received the protocol treatment: 34 in Arm A and 31 in Arm B.
Defined by radiographic response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or prostate specific antigen \[PSA\] response (\> 50% decline from baseline).
Outcome measures
| Measure |
Arm A (Docetaxel, Carboplatin)
n=34 Participants
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes, or carboplatin alone on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who have PSA progression or radiographic progression may crossover to Arm B.
|
Arm B (Carboplatin, Berzosertib)
n=31 Participants
Patients receive carboplatin IV over 30 minutes on day 1 and berzosertib IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Response Rate
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the time of randomization up to 2 yearsPopulation: The analysis population included the 65 subjects who received the protocol treatment: 34 in Arm A and 31 in Arm B.
Assessed by Prostate Cancer Working Group (PCWG) 3 criteria. PFS to be estimated with the Kaplan Meier methodology. Median will be provided with 95% confidence interval.
Outcome measures
| Measure |
Arm A (Docetaxel, Carboplatin)
n=34 Participants
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes, or carboplatin alone on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who have PSA progression or radiographic progression may crossover to Arm B.
|
Arm B (Carboplatin, Berzosertib)
n=31 Participants
Patients receive carboplatin IV over 30 minutes on day 1 and berzosertib IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
2.5 Months
Interval 2.1 to 4.2
|
2.4 Months
Interval 2.1 to 3.5
|
SECONDARY outcome
Timeframe: From the time of randomization up to 2 yearsPopulation: The analysis population included the 65 subjects who received the protocol treatment: 34 in Arm A and 31 in Arm B.
Assessed by PCWG2. PSA progression will be estimated with the Kaplan Meier methodology. Median will be provided with 95% confidence interval.
Outcome measures
| Measure |
Arm A (Docetaxel, Carboplatin)
n=34 Participants
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes, or carboplatin alone on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who have PSA progression or radiographic progression may crossover to Arm B.
|
Arm B (Carboplatin, Berzosertib)
n=31 Participants
Patients receive carboplatin IV over 30 minutes on day 1 and berzosertib IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Time to PSA Progression
|
2.1 Months
Interval 1.4 to 3.6
|
1.4 Months
Interval 1.0 to 2.8
|
SECONDARY outcome
Timeframe: From the time of randomization up to 2 yearsPopulation: The analysis population included the 65 subjects who received the protocol treatment: 34 in Arm A and 31 in Arm B.
Assessed by RECIST 1.1 for non-osseous disease and by PCWG3 for osseous disease. rPFS will be estimated with the Kaplan Meier methodology. Median will be provided with 95% confidence interval.
Outcome measures
| Measure |
Arm A (Docetaxel, Carboplatin)
n=34 Participants
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes, or carboplatin alone on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who have PSA progression or radiographic progression may crossover to Arm B.
|
Arm B (Carboplatin, Berzosertib)
n=31 Participants
Patients receive carboplatin IV over 30 minutes on day 1 and berzosertib IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Radiographic Progression-free Survival (rPFS)
|
3.2 Months
Interval 2.1 to 5.1
|
2.6 Months
Interval 2.1 to 4.8
|
SECONDARY outcome
Timeframe: Up to 2 years (from treatment initiation to 30 days after the last dose of study treatment)Population: The analysis population included the 65 subjects who received the protocol treatment: 34 in Arm A and 31 in Arm B.
Adverse events will be graded and analyzed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Outcome measures
| Measure |
Arm A (Docetaxel, Carboplatin)
n=34 Participants
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes, or carboplatin alone on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who have PSA progression or radiographic progression may crossover to Arm B.
|
Arm B (Carboplatin, Berzosertib)
n=31 Participants
Patients receive carboplatin IV over 30 minutes on day 1 and berzosertib IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Incidence of Adverse Events
|
34 Participants
|
31 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the time of randomization up to 2 yearsPopulation: The analysis population included the 65 subjects who received the protocol treatment: 34 in Arm A and 31 in Arm B.
OS will be estimated with the Kaplan Meier methodology.
Outcome measures
| Measure |
Arm A (Docetaxel, Carboplatin)
n=34 Participants
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes, or carboplatin alone on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who have PSA progression or radiographic progression may crossover to Arm B.
|
Arm B (Carboplatin, Berzosertib)
n=31 Participants
Patients receive carboplatin IV over 30 minutes on day 1 and berzosertib IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival (OS)
|
8.4 Months
Interval 4.5 to 12.8
|
5.7 Months
Interval 4.6 to 8.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baselinePopulation: Only 36 subjects had HR mutation data from baseline tumor biopsies: 22 in Arm A and 14 in Arm B.
The frequency of homologous recombination (HR) deficiency detected from baseline tumor biopsy is summarized by arm at baseline.
Outcome measures
| Measure |
Arm A (Docetaxel, Carboplatin)
n=22 Participants
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes, or carboplatin alone on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who have PSA progression or radiographic progression may crossover to Arm B.
|
Arm B (Carboplatin, Berzosertib)
n=14 Participants
Patients receive carboplatin IV over 30 minutes on day 1 and berzosertib IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gene Mutation Frequencies
|
3 Participants
|
3 Participants
|
Adverse Events
Arm A (Docetaxel, Carboplatin)
Serious events: 11 serious events
Other events: 34 other events
Deaths: 1 deaths
Arm B (Carboplatin, Berzosertib)
Serious events: 14 serious events
Other events: 31 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm A (Docetaxel, Carboplatin)
n=34 participants at risk
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes, or carboplatin alone on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who have PSA progression or radiographic progression may crossover to Arm B.
|
Arm B (Carboplatin, Berzosertib)
n=31 participants at risk
Patients receive carboplatin IV over 30 minutes on day 1 and berzosertib IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
19.4%
6/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Cardiac disorders
Demand Ischemia
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Cardiac disorders
Myocardial Infarction
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Gastrointestinal disorders
Rectal Obstruction
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Gastrointestinal disorders
Rectal Pain
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
General disorders
Death Nos
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
General disorders
Edema Limbs
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
General disorders
Fatigue
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
General disorders
Fever
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
12.9%
4/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
General disorders
Gait Disturbance
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
General disorders
Malaise
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
General disorders
Pain
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Infections and infestations
Enterocolitis Infectious
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Infections and infestations
Lung Infection
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Infections and infestations
Sepsis
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Infections and infestations
Urinary Tract Infection
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Injury, poisoning and procedural complications
Fracture
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
Alanine Aminotransferase Increased
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
Aspartate Aminotransferase Increased
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
Blood Bilirubin Increased
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
Creatinine Increased
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
Neutrophil Count Decreased
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
Platelet Count Decreased
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Musculoskeletal and connective tissue disorders
Pathologic Fracture
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive Disease
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Nervous system disorders
Encephalophathy
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Nervous system disorders
Headache
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Psychiatric disorders
Confusion
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Renal and urinary disorders
Hematuria
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Vascular disorders
Hypotension
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
Other adverse events
| Measure |
Arm A (Docetaxel, Carboplatin)
n=34 participants at risk
Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes, or carboplatin alone on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who have PSA progression or radiographic progression may crossover to Arm B.
|
Arm B (Carboplatin, Berzosertib)
n=31 participants at risk
Patients receive carboplatin IV over 30 minutes on day 1 and berzosertib IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
52.9%
18/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
64.5%
20/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
Platelet Count Decreased
|
47.1%
16/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
64.5%
20/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
General disorders
Fatigue
|
41.2%
14/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
48.4%
15/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Gastrointestinal disorders
Nausea
|
32.4%
11/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
41.9%
13/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Gastrointestinal disorders
Constipation
|
29.4%
10/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
45.2%
14/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
Aspartate Aminotransferase Increased
|
26.5%
9/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
19.4%
6/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Anorexia
|
26.5%
9/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
35.5%
11/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Gastrointestinal disorders
Diarrhea
|
20.6%
7/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
19.4%
6/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
Neutrophil Count Decreased
|
20.6%
7/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
22.6%
7/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Gastrointestinal disorders
Abdominal Pain
|
17.6%
6/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
9.7%
3/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.6%
6/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
22.6%
7/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Nervous system disorders
Dysgeusia
|
17.6%
6/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
12.9%
4/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
Alkaline Phosphatase Increased
|
14.7%
5/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
16.1%
5/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
White Blood Cell Decreased
|
14.7%
5/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
35.5%
11/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.7%
5/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Renal and urinary disorders
Hematuria
|
14.7%
5/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
16.1%
5/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
4/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
16.1%
5/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
General disorders
Edema Limbs
|
11.8%
4/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
Alanine Aminotransferase Increased
|
11.8%
4/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
9.7%
3/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
11.8%
4/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
Lymphocyte Count Decreased
|
11.8%
4/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
22.6%
7/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
Weight Loss
|
11.8%
4/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
22.6%
7/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.8%
4/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
19.4%
6/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.8%
4/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
12.9%
4/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
11.8%
4/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
12.9%
4/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
11.8%
4/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
4/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.8%
4/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
32.3%
10/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Eye disorders
Watering Eyes
|
8.8%
3/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.8%
3/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
16.1%
5/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.8%
3/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
19.4%
6/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.8%
3/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
19.4%
6/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Nervous system disorders
Tremor
|
8.8%
3/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Vascular disorders
Hypotension
|
8.8%
3/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
12.9%
4/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Cardiac disorders
Sinus Tachycardia
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
12.9%
4/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
General disorders
Chills
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
9.7%
3/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
General disorders
Fever
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
25.8%
8/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
General disorders
Generalized Edema
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
General disorders
Pain
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
12.9%
4/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Infections and infestations
Thrush
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
0.00%
0/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Infections and infestations
Upper Respiratory Infection
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Infections and infestations
Urinary Tract Infection
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
12.9%
4/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
Creatinine Increased
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
22.6%
7/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
3.2%
1/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
19.4%
6/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
19.4%
6/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Nervous system disorders
Dizziness
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
25.8%
8/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Nervous system disorders
Headache
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
9.7%
3/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Nervous system disorders
Paresthesia
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
9.7%
3/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Vascular disorders
Thromboembolic Event
|
5.9%
2/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
9.7%
3/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Ear and labyrinth disorders
Tinnitus
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Injury, poisoning and procedural complications
Bruising
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Investigations
LDH increase
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
9.7%
3/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
9.7%
3/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
12.9%
4/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Psychiatric disorders
Depression
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Reproductive system and breast disorders
Pelvic Pain
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
9.7%
3/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Vascular disorders
Hot Flashes
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Vascular disorders
Hypertension
|
2.9%
1/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
9.7%
3/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
9.7%
3/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/34 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
6.5%
2/31 • From treatment initiation to 30 days after the last dose of study treatment, up to 2 years
The analysis population includes 65 subjects who receive the study treatment (Arm A: 34; Arm B: 31). Adverse events are graded using Common Terminology Criteria for Adverse Events version 5.0. All-cause mortalities capture deaths within 30-days post-treatment. Serious AEs (SAE) include clinically significant AEs that are fatal, life-threatening, hospitalization-requiring, or require intervention to prevent permanent impairment; all other AEs are no-SAEs (maximum grade reported).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60