Trial Outcomes & Findings for Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis (NCT NCT03317392)
NCT ID: NCT03317392
Last Updated: 2026-05-20
Results Overview
Determine the maximum tolerated dose (MTD) of olaparib in combination with radium Ra 223 dichloride (radium-223). (Phase I)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
132 participants
Primary outcome timeframe
56 days
Results posted on
2026-05-20
Participant Flow
Participant milestones
| Measure |
Phase I Radium223+Olaparib Dose Level 1
Dose level I: Radium223 plus olaparib 200 mg orally twice daily
|
Phase I Radium223+Olaparib Dose Level 2
Dose level II: Radium223 plus olaparib 300 mg orally twice daily
|
Phase II Arm I (Radium Ra 223 Dichloride, Olaparib)
Patients receive radium Ra 223 dichloride IV over 1 minute on day 1. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI as well as blood sample collection and a tissue biopsy during screening and on study.
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase II Arm II (Radium Ra 223 Dichloride)
Patients receive radium Ra 223 dichloride as in Arm I. Patients with radiographic progression may crossover to Arm I. If patients have already completed all 6 infusions of radium, they will receive monotherapy with olaparib. If they have not yet completed all 6 radium-223 infusion, they will continue radium-223 infusion until completion and receive concurrent treatment with olaparib. Patients also undergo CT or MRI as well as blood sample collection and a tissue biopsy during screening and on study.
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
61
|
59
|
|
Overall Study
COMPLETED
|
6
|
6
|
59
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
4
|
Reasons for withdrawal
| Measure |
Phase I Radium223+Olaparib Dose Level 1
Dose level I: Radium223 plus olaparib 200 mg orally twice daily
|
Phase I Radium223+Olaparib Dose Level 2
Dose level II: Radium223 plus olaparib 300 mg orally twice daily
|
Phase II Arm I (Radium Ra 223 Dichloride, Olaparib)
Patients receive radium Ra 223 dichloride IV over 1 minute on day 1. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI as well as blood sample collection and a tissue biopsy during screening and on study.
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase II Arm II (Radium Ra 223 Dichloride)
Patients receive radium Ra 223 dichloride as in Arm I. Patients with radiographic progression may crossover to Arm I. If patients have already completed all 6 infusions of radium, they will receive monotherapy with olaparib. If they have not yet completed all 6 radium-223 infusion, they will continue radium-223 infusion until completion and receive concurrent treatment with olaparib. Patients also undergo CT or MRI as well as blood sample collection and a tissue biopsy during screening and on study.
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
|---|---|---|---|---|
|
Overall Study
Did not receive study therapy
|
0
|
0
|
2
|
4
|
Baseline Characteristics
Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis
Baseline characteristics by cohort
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=6 Participants
Dose level I: Radium223 at 55 kBq/kg q4w plus olaparib 200 mg orally twice daily
|
Phase I Radium223+Olaparib Dose Level 2
n=6 Participants
Dose level II: Radium223 at 55 kBq/kg q4w plus olaparib 300 mg orally twice daily
|
Phase II Arm I (Radium Ra 223 Dichloride, Olaparib)
n=61 Participants
Patients receive radium Ra 223 dichloride IV over 1 minute on day 1. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI as well as blood sample collection and a tissue biopsy during screening and on study.
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase II Arm II (Radium Ra 223 Dichloride)
n=59 Participants
Patients receive radium Ra 223 dichloride as in Arm I. Patients with radiographic progression may crossover to Arm I. If patients have already completed all 6 infusions of radium, they will receive monotherapy with olaparib. If they have not yet completed all 6 radium-223 infusion, they will continue radium-223 infusion until completion and receive concurrent treatment with olaparib. Patients also undergo CT or MRI as well as blood sample collection and a tissue biopsy during screening and on study.
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
6 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
61 Participants
n=60 Participants
|
59 Participants
n=133 Participants
|
132 Participants
n=6 Participants
|
|
Age, Continuous
|
67 years
n=30 Participants
|
68 years
n=30 Participants
|
69 years
n=60 Participants
|
71 years
n=133 Participants
|
70 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
0 Participants
n=133 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
6 Participants
n=133 Participants
|
9 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
53 Participants
n=60 Participants
|
50 Participants
n=133 Participants
|
114 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=133 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
3 Participants
n=133 Participants
|
7 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=30 Participants
|
6 participants
n=30 Participants
|
61 participants
n=60 Participants
|
59 participants
n=133 Participants
|
132 participants
n=6 Participants
|
|
Previous use of androgen receptor pathway inhibitors
|
6 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
59 Participants
n=60 Participants
|
56 Participants
n=133 Participants
|
127 Participants
n=6 Participants
|
|
Previous use of any chemotherapy
|
2 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
34 Participants
n=60 Participants
|
30 Participants
n=133 Participants
|
67 Participants
n=6 Participants
|
|
Previous use of docetaxel
|
2 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
32 Participants
n=60 Participants
|
30 Participants
n=133 Participants
|
65 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 56 daysDetermine the maximum tolerated dose (MTD) of olaparib in combination with radium Ra 223 dichloride (radium-223). (Phase I)
Outcome measures
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=6 Participants
Dose level I: Radium223 plus olaparib 200 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase I Radium223+Olaparib Dose Level 2
n=6 Participants
Dose level II: Radium223 plus olaparib 300 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
|---|---|---|
|
Phase I: Maximum Tolerated Dose
|
200 mg
|
200 mg
|
PRIMARY outcome
Timeframe: From randomization to date of radiographic progression or death due to any cause, whichever occurs first, or censored at the date of last disease assessment. Up to approximately 2 yearsRadiographic progression is defined by Prostate Cancer Working Group 3 criteria for bone metastases and RECIST version 1.1 for non-bone metastases. Median rPFS will be estimated using the Kaplan-Meier method by treatment arm. A stratified Cox proportional hazards regression model will estimate the rPFS treatment hazard ratio with 80% 2-sided confidence intervals (CIs). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions",
Outcome measures
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=61 Participants
Dose level I: Radium223 plus olaparib 200 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase I Radium223+Olaparib Dose Level 2
n=59 Participants
Dose level II: Radium223 plus olaparib 300 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
|---|---|---|
|
Phase II: Radiographic Progression-free Survival (rPFS)
|
8.9 months
Interval 5.4 to 13.7
|
4.7 months
Interval 3.2 to 6.0
|
SECONDARY outcome
Timeframe: Up to approximately 2 years after randomizationMedian rPFS will be estimated using the Kaplan-Meier method by treatment arm.
Outcome measures
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=29 Participants
Dose level I: Radium223 plus olaparib 200 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase I Radium223+Olaparib Dose Level 2
n=29 Participants
Dose level II: Radium223 plus olaparib 300 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
|---|---|---|
|
Phase II: rPFS in Patients Without Prior Docetaxel
|
13.7 months
Interval 11.3 to 17.2
|
5.7 months
Interval 3.3 to 8.3
|
SECONDARY outcome
Timeframe: Up to approximately 2 years after randomizationMedian rPFS will be estimated using the Kaplan-Meier method by treatment arm.
Outcome measures
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=32 Participants
Dose level I: Radium223 plus olaparib 200 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase I Radium223+Olaparib Dose Level 2
n=30 Participants
Dose level II: Radium223 plus olaparib 300 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
|---|---|---|
|
Phase II: rPFS in Patients With Prior Docetaxel
|
6.6 months
Interval 3.3 to 8.9
|
3.3 months
Interval 2.9 to 5.6
|
SECONDARY outcome
Timeframe: Up to approximately 2 years after randomizationMedian rPFS will be estimated using the Kaplan-Meier method by treatment arm.
Outcome measures
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=33 Participants
Dose level I: Radium223 plus olaparib 200 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase I Radium223+Olaparib Dose Level 2
n=31 Participants
Dose level II: Radium223 plus olaparib 300 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
|---|---|---|
|
Phase II: rPFS in Patients With ≤ 20 Bone Lesions
|
13.4 months
Interval 11.3 to 17.0
|
4.1 months
Interval 2.9 to 5.7
|
SECONDARY outcome
Timeframe: Up to approximately 2 years after randomizationMedian rPFS will be estimated using the Kaplan-Meier method by treatment arm.
Outcome measures
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=28 Participants
Dose level I: Radium223 plus olaparib 200 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase I Radium223+Olaparib Dose Level 2
n=28 Participants
Dose level II: Radium223 plus olaparib 300 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
|---|---|---|
|
Phase II: rPFS in Patients With > 20 Bone Lesions
|
4.7 months
Interval 3.1 to 8.8
|
4.8 months
Interval 3.1 to 11.0
|
SECONDARY outcome
Timeframe: From randomization to the date of death due to any cause, or censored at the date of last follow-up, assessed up to 3.5 yearsPhase II: Median OS will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=61 Participants
Dose level I: Radium223 plus olaparib 200 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase I Radium223+Olaparib Dose Level 2
n=59 Participants
Dose level II: Radium223 plus olaparib 300 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
|---|---|---|
|
Phase II: Overall Survival (OS)
|
20.2 months
Interval 13.8 to 25.7
|
21.1 months
Interval 14.4 to 23.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 2 years after randomizationrPFS in patients without homologous recombination deficiency
Outcome measures
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=31 Participants
Dose level I: Radium223 plus olaparib 200 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase I Radium223+Olaparib Dose Level 2
n=23 Participants
Dose level II: Radium223 plus olaparib 300 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
|---|---|---|
|
Phase II: rPFS in Patients Without Homologous Recombination Deficiency
|
5.7 months
Interval 3.1 to 15.8
|
5.6 months
Interval 3.3 to 11.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 2 years after randomizationrPFS in patients with homologous recombination deficiency
Outcome measures
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=8 Participants
Dose level I: Radium223 plus olaparib 200 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase I Radium223+Olaparib Dose Level 2
n=5 Participants
Dose level II: Radium223 plus olaparib 300 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
|---|---|---|
|
Phase II: rPFS in Patients With Homologous Recombination Deficiency
|
13.9 months
Interval 4.7 to 99.0
|
3.0 months
Interval 2.9 to 10.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 2 years after randomizationNumber of participants with prostate specific antigen (PSA) response defined as PSA ≥50% decrease from baseline
Outcome measures
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=61 Participants
Dose level I: Radium223 plus olaparib 200 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase I Radium223+Olaparib Dose Level 2
n=59 Participants
Dose level II: Radium223 plus olaparib 300 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
|---|---|---|
|
Phase II: Prostate Specific Antigen (PSA) Response
|
9 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 2 years after randomizationAlkaline phosphatase (ALP) response defined as ≥30% decrease from baseline.
Outcome measures
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=61 Participants
Dose level I: Radium223 plus olaparib 200 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase I Radium223+Olaparib Dose Level 2
n=59 Participants
Dose level II: Radium223 plus olaparib 300 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
|---|---|---|
|
Phase II: Alkaline Phosphatase (ALP) Response
|
30 Participants
|
30 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 2 years after randomizationSymptomatic skeletal event (SSE) defined as pathologic bone fracture, spinal cord compression, or radiation therapy to bone.
Outcome measures
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=61 Participants
Dose level I: Radium223 plus olaparib 200 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase I Radium223+Olaparib Dose Level 2
n=59 Participants
Dose level II: Radium223 plus olaparib 300 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
|---|---|---|
|
Phase II: Symptomatic Skeletal Event (SSE)
|
12.7 Percent of participants
Interval 4.9 to 24.2
|
22.9 Percent of participants
Interval 9.5 to 39.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to approximately 2 years after randomizationIncidence of grade 3 or higher treatment related adverse events (TrAE)
Outcome measures
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=59 Participants
Dose level I: Radium223 plus olaparib 200 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase I Radium223+Olaparib Dose Level 2
n=55 Participants
Dose level II: Radium223 plus olaparib 300 mg orally twice daily
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
|---|---|---|
|
Phase II: Incidence of Grade 3 or Higher Treatment Related Adverse Events (TrAE)
|
44 events
|
23 events
|
Adverse Events
Phase I Radium223+Olaparib Dose Level 1
Serious events: 4 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase I Radium223+Olaparib Dose Level 2
Serious events: 2 serious events
Other events: 6 other events
Deaths: 3 deaths
Phase II Arm I (Radium Ra 223 Dichloride, Olaparib)
Serious events: 39 serious events
Other events: 59 other events
Deaths: 38 deaths
Phase II Arm II (Radium Ra 223 Dichloride)
Serious events: 29 serious events
Other events: 55 other events
Deaths: 18 deaths
Phase II Arm I After Cross-over From Arm II (Radium Ra 223 Dichloride, Olaparib)
Serious events: 11 serious events
Other events: 23 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=6 participants at risk
Dose level I: Radium223 at 55 kBq/kg q4w plus olaparib 200 mg orally twice daily
|
Phase I Radium223+Olaparib Dose Level 2
n=6 participants at risk
Dose level II: Radium223 at 55 kBq/kg q4w plus olaparib 300 mg orally twice daily
|
Phase II Arm I (Radium Ra 223 Dichloride, Olaparib)
n=59 participants at risk
Patients receive radium Ra 223 dichloride IV at 55 kBq/kg over 1 minute on day 1. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive olaparib 200 mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI as well as blood sample collection and a tissue biopsy during screening and on study.
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase II Arm II (Radium Ra 223 Dichloride)
n=55 participants at risk
Patients receive radium Ra 223 dichloride as in Arm I. Patients with radiographic progression may crossover to Arm I. If patients have already completed all 6 infusions of radium, they will receive monotherapy with olaparib. If they have not yet completed all 6 radium-223 infusion, they will continue radium-223 infusion until completion and receive concurrent treatment with olaparib. Patients also undergo CT or MRI as well as blood sample collection and a tissue biopsy during screening and on study.
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase II Arm I After Cross-over From Arm II (Radium Ra 223 Dichloride, Olaparib)
n=23 participants at risk
Patient initially assigned to Arm II will have the option to cross over to Arm I treatment at radiographic progression.
Radium 223 IV at 55 kBq/kg up to 6 cycles. Olaparib 200 mg orally twice daily
|
|---|---|---|---|---|---|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
33.3%
2/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
30.5%
18/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
14.5%
8/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
26.1%
6/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
22.0%
13/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
18.2%
10/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.7%
2/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.5%
5/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.1%
3/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.7%
2/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
6.8%
4/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
6.8%
4/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.6%
2/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.1%
3/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
General disorders
Disease progression
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
General disorders
Pain
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Cardiac disorders
Asystole
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Eye disorders
Vision decreased
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Blood in the stool
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
General disorders
Death NOS
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
General disorders
Fever
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Weight loss
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Vascular disorders
Hematoma
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
Other adverse events
| Measure |
Phase I Radium223+Olaparib Dose Level 1
n=6 participants at risk
Dose level I: Radium223 at 55 kBq/kg q4w plus olaparib 200 mg orally twice daily
|
Phase I Radium223+Olaparib Dose Level 2
n=6 participants at risk
Dose level II: Radium223 at 55 kBq/kg q4w plus olaparib 300 mg orally twice daily
|
Phase II Arm I (Radium Ra 223 Dichloride, Olaparib)
n=59 participants at risk
Patients receive radium Ra 223 dichloride IV at 55 kBq/kg over 1 minute on day 1. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive olaparib 200 mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI as well as blood sample collection and a tissue biopsy during screening and on study.
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase II Arm II (Radium Ra 223 Dichloride)
n=55 participants at risk
Patients receive radium Ra 223 dichloride as in Arm I. Patients with radiographic progression may crossover to Arm I. If patients have already completed all 6 infusions of radium, they will receive monotherapy with olaparib. If they have not yet completed all 6 radium-223 infusion, they will continue radium-223 infusion until completion and receive concurrent treatment with olaparib. Patients also undergo CT or MRI as well as blood sample collection and a tissue biopsy during screening and on study.
Biopsy Procedure: Undergo tissue biopsy
Biospecimen Collection: Undergo blood sample collection
Computed Tomography: Undergo CT
Laboratory Biomarker Analysis: Correlative studies
Magnetic Resonance Imaging: Undergo MRI
Quality-of-Life Assessment: Ancillary studies
Radium Ra 223 Dichloride: Given IV
|
Phase II Arm I After Cross-over From Arm II (Radium Ra 223 Dichloride, Olaparib)
n=23 participants at risk
Patient initially assigned to Arm II will have the option to cross over to Arm I treatment at radiographic progression.
Radium 223 IV at 55 kBq/kg up to 6 cycles. Olaparib 200 mg orally twice daily
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
3/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
66.7%
4/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
74.6%
44/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
58.2%
32/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
60.9%
14/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
General disorders
Fatigue
|
100.0%
6/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
83.3%
5/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
67.8%
40/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
50.9%
28/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
26.1%
6/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
66.7%
4/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
55.9%
33/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
49.1%
27/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
56.5%
13/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
66.7%
4/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
52.5%
31/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
49.1%
27/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
43.5%
10/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
50.0%
3/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
50.8%
30/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
38.2%
21/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
34.8%
8/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
33.3%
2/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
47.5%
28/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
40.0%
22/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
26.1%
6/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Eye disorders
Floaters
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
33.3%
2/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
32.2%
19/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
38.2%
21/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
39.1%
9/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Platelet count decreased
|
33.3%
2/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
33.3%
2/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
37.3%
22/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
27.3%
15/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
26.1%
6/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Weight loss
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
33.9%
20/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
29.1%
16/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
21.7%
5/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
20.3%
12/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
27.3%
15/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
39.1%
9/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
32.2%
19/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
23.6%
13/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
13.0%
3/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
General disorders
Pain
|
50.0%
3/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
23.7%
14/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
18.2%
10/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
30.4%
7/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
33.3%
2/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
23.7%
14/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
21.8%
12/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
21.7%
5/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
30.5%
18/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
20.0%
11/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
17.4%
4/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Blood lactate dehydrogenase increased
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
22.0%
13/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
14.5%
8/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
39.1%
9/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
22.0%
13/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
18.2%
10/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
17.4%
4/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
22.0%
13/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
18.2%
10/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
21.7%
5/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
33.3%
2/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.9%
10/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
20.0%
11/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
17.4%
4/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
32.2%
19/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
10.9%
6/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
23.7%
14/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
9.1%
5/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
13.0%
3/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
15.3%
9/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
20.0%
11/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
17.4%
4/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
33.3%
2/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
22.0%
13/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
14.5%
8/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
18.6%
11/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
12.7%
7/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
13.0%
3/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
33.3%
2/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
20.3%
12/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
13.0%
3/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
10.2%
6/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
9.1%
5/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
21.7%
5/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
18.6%
11/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
7.3%
4/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
13.6%
8/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
10.9%
6/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.7%
2/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
11.9%
7/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
12.7%
7/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.7%
2/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
13.6%
8/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
9.1%
5/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.7%
2/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.5%
5/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
12.7%
7/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.7%
2/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
11.9%
7/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
9.1%
5/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
13.0%
3/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
18.6%
11/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.6%
2/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
13.6%
8/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.7%
2/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.5%
5/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
9.1%
5/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
13.0%
3/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
11.9%
7/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
9.1%
5/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
6.8%
4/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
10.9%
6/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
13.6%
8/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
10.2%
6/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
9.1%
5/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.5%
5/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
13.0%
3/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
12.7%
7/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.7%
2/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
9.1%
5/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
13.0%
3/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
6.8%
4/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.6%
2/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
17.4%
4/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Nervous system disorders
Paresthesia
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
10.2%
6/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.6%
2/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
10.2%
6/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Vascular disorders
Hot flashes
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.5%
5/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
7.3%
4/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
General disorders
Chills
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
11.9%
7/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
6.8%
4/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.1%
3/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.6%
2/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.7%
2/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
6.8%
4/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
6.8%
4/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
6.8%
4/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.6%
2/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.1%
3/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.6%
2/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.7%
2/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
6.8%
4/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
6.8%
4/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.6%
2/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
7.3%
4/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
7.3%
4/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
7.3%
4/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.7%
2/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.1%
3/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.6%
2/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.7%
2/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.1%
3/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.6%
2/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
7.3%
4/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Bloating
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.1%
3/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
2/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
6.8%
4/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.6%
2/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
13.0%
3/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.1%
3/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.6%
2/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.1%
3/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.6%
2/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.1%
3/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.5%
3/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.1%
3/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.1%
3/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
3.4%
2/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
4.3%
1/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.1%
3/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.1%
3/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.8%
1/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.7%
2/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
5.1%
3/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Cardiac disorders
Chest pain - cardiac
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
8.7%
2/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
1.7%
1/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Eye disorders
Eye irritation
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
General disorders
Generalized edema
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Investigations
Chloride increased
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Musculoskeletal and connective tissue disorders
wrist swelling
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Nervous system disorders
Stroke
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
16.7%
1/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/6 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/59 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/55 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
0.00%
0/23 • Adverse events (AE) are assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5 by treatment arm, from enrollment until end of study visit, up to approximately 2.5 years after randomization. All-Cause Mortality monitored/assessed up to 3.5 years.
AE analyses include patients that actually receiving treatment. A serious AE (SAE) includes an AE that results in any of 1)death, 2)a life-threatening event, 3)inpatient hospitalization or prolonged hospitalization for ≥24 hours, 4)persistent/significant incapacity, or substantial disruption of the ability to conduct normal life functions, 5)a congenital anomaly or birth defect, 6)need for medical/surgical intervention to prevent any outcome above. Other AEs include non-SAE events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60