Trial Outcomes & Findings for A Study of Silmitasertib (CX-4945) in Healthy Subject (NCT NCT05817708)
NCT ID: NCT05817708
Last Updated: 2025-01-27
Results Overview
Evaluate the number adverse events occurring from Day 1 to Day 5 as characterized by type, frequency, severity \[as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0\], timing, seriousness, and relationship to study therapy after administration of 200mg QD, 200mg BID and 400mg BID for continuously 5 days to healthy subjects.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Day 1 to Day 5
Results posted on
2025-01-27
Participant Flow
Participants were recruited from healthy subjects at Taipei Medical University Hospital between November 2022 and December 2022. The first participant was enrolled on November 28th, 2022, and the last was enrolled in 28th December 2022.
30 enrolled participants met inclusion criteria and were randomized.
Participant milestones
| Measure |
CX-4945 200mg QD
CX-4945 will be administered at 200mg QD for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 200mg BID
CX-4945 will be administered at 200mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 400mg BID
CX-4945 will be administered at 400mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Silmitasertib (CX-4945) in Healthy Subject
Baseline characteristics by cohort
| Measure |
CX-4945 200mg QD
n=10 Participants
CX-4945 was administered at 200mg QD for continuously 5 days.
|
CX-4945 200mg BID
n=10 Participants
CX-4945 was administered at 200mg BID for continuously 5 days.
|
CX-4945 400mg BID
n=10 Participants
CX-4945 was administered at 400mg BID for continuously 5 days.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.5 years
n=99 Participants
|
32 years
n=107 Participants
|
37.5 years
n=206 Participants
|
33.5 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
Taiwan
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
10 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 5Population: Treatment-Emergent Adverse Events
Evaluate the number adverse events occurring from Day 1 to Day 5 as characterized by type, frequency, severity \[as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0\], timing, seriousness, and relationship to study therapy after administration of 200mg QD, 200mg BID and 400mg BID for continuously 5 days to healthy subjects.
Outcome measures
| Measure |
CX-4945 200mg QD
n=10 Participants
CX-4945 will be administered at 200mg QD for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 200mg BID
n=10 Participants
CX-4945 will be administered at 200mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 400mg BID
n=10 Participants
CX-4945 will be administered at 400mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAT)
|
1 Participants
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 6Population: Day 6 (EOT) - Change from Baseline
Changes ALP in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Outcome measures
| Measure |
CX-4945 200mg QD
n=10 Participants
CX-4945 will be administered at 200mg QD for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 200mg BID
n=10 Participants
CX-4945 will be administered at 200mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 400mg BID
n=10 Participants
CX-4945 will be administered at 400mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
|---|---|---|---|
|
Evaluate Changes in Blood Chemistry.
|
-2.1 U/L
Standard Deviation 5.78
|
-0.3 U/L
Standard Deviation 6.62
|
3.4 U/L
Standard Deviation 2.84
|
SECONDARY outcome
Timeframe: Day 1 to Day 6Population: Day 6 (EOT) - Change from Baseline
Changes AST in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Outcome measures
| Measure |
CX-4945 200mg QD
n=10 Participants
CX-4945 will be administered at 200mg QD for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 200mg BID
n=10 Participants
CX-4945 will be administered at 200mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 400mg BID
n=10 Participants
CX-4945 will be administered at 400mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
|---|---|---|---|
|
Evaluate Changes in Blood Chemistry.
|
-3.9 U/L
Standard Deviation 5.11
|
-2.4 U/L
Standard Deviation 3.72
|
0.1 U/L
Standard Deviation 3.35
|
SECONDARY outcome
Timeframe: Day 1 to Day 6Population: Day 6 (EOT) - Change from Baseline
Changes ALT in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Outcome measures
| Measure |
CX-4945 200mg QD
n=10 Participants
CX-4945 will be administered at 200mg QD for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 200mg BID
n=10 Participants
CX-4945 will be administered at 200mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 400mg BID
n=10 Participants
CX-4945 will be administered at 400mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
|---|---|---|---|
|
To Evaluate Changes in Blood Chemistry.
|
-4.0 U/L
Standard Deviation 6.15
|
-1.4 U/L
Standard Deviation 5.19
|
0.9 U/L
Standard Deviation 4.77
|
SECONDARY outcome
Timeframe: Day 1 to Day 6Population: Day 6 (EOT) - Change from Baseline
Changes LDH in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Outcome measures
| Measure |
CX-4945 200mg QD
n=10 Participants
CX-4945 will be administered at 200mg QD for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 200mg BID
n=10 Participants
CX-4945 will be administered at 200mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 400mg BID
n=10 Participants
CX-4945 will be administered at 400mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
|---|---|---|---|
|
To Evaluate Changes in Blood Chemistry.
|
-17.0 U/L
Standard Deviation 17.17
|
-26.2 U/L
Standard Deviation 10.75
|
-28.2 U/L
Standard Deviation 14.33
|
SECONDARY outcome
Timeframe: Day 1 to Day 6Population: Day 6 (EOT) - Change from Baseline
Changes CPK in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Outcome measures
| Measure |
CX-4945 200mg QD
n=10 Participants
CX-4945 will be administered at 200mg QD for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 200mg BID
n=10 Participants
CX-4945 will be administered at 200mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 400mg BID
n=10 Participants
CX-4945 will be administered at 400mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
|---|---|---|---|
|
To Evaluate Changes in Blood Chemistry.
|
-24.3 U/L
Standard Deviation 19.35
|
-54.0 U/L
Standard Deviation 63.71
|
-65.1 U/L
Standard Deviation 71.37
|
SECONDARY outcome
Timeframe: Day 1 to Day 6Population: Day 6 (EOT) - Change from Baseline
Changes CRP in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Outcome measures
| Measure |
CX-4945 200mg QD
n=10 Participants
CX-4945 will be administered at 200mg QD for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 200mg BID
n=10 Participants
CX-4945 will be administered at 200mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 400mg BID
n=10 Participants
CX-4945 will be administered at 400mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
|---|---|---|---|
|
To Evaluate Changes in Blood Chemistry.
|
0.003 mg/dL
Standard Deviation 0.1341
|
-0.071 mg/dL
Standard Deviation 0.2497
|
0.002 mg/dL
Standard Deviation 0.0447
|
SECONDARY outcome
Timeframe: Screening, Day 1, Day 3, Day 5, and Day 6Population: \[Not Specified\]
ECG assessments were done during Screening, Day 1, Day 3, Day 5, and Day 6. A 12-lead ECG was performed at baseline (Day1), Day 3, Day 5, and Day 6 and categorized as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS).
Outcome measures
| Measure |
CX-4945 200mg QD
n=10 Participants
CX-4945 will be administered at 200mg QD for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 200mg BID
n=10 Participants
CX-4945 will be administered at 200mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 400mg BID
n=10 Participants
CX-4945 will be administered at 400mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
|---|---|---|---|
|
Number of Participants Evaluated as Having Abnormalities (CS or NCS) in Their ECG
Screening
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants Evaluated as Having Abnormalities (CS or NCS) in Their ECG
Day 1 (Baseline)
|
3 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants Evaluated as Having Abnormalities (CS or NCS) in Their ECG
Day 3
|
7 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants Evaluated as Having Abnormalities (CS or NCS) in Their ECG
Day 5
|
5 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants Evaluated as Having Abnormalities (CS or NCS) in Their ECG
Day 6
|
6 Participants
|
6 Participants
|
6 Participants
|
Adverse Events
CX-4945 200mg BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CX-4945 200mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CX-4945 400mg BID
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CX-4945 200mg BID
n=10 participants at risk
CX-4945 will be administered at 200mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 200mg QD
n=10 participants at risk
CX-4945 will be administered at 200mg QD for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
CX-4945 400mg BID
n=10 participants at risk
CX-4945 will be administered at 400mg BID for continuously 5 days.
CX-4945: Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
|
|---|---|---|---|
|
Gastrointestinal disorders
Dirrhoea
|
0.00%
0/10 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
10.0%
1/10 • Number of events 1 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
60.0%
6/10 • Number of events 6 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/10 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
10.0%
1/10 • Number of events 1 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 3 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/10 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/10 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • Number of events 1 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/10 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/10 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/10 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
10.0%
1/10 • Number of events 1 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
10.0%
1/10 • Number of events 1 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Investigations
C-reactive protein abnormal
|
0.00%
0/10 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
20.0%
2/10 • Number of events 2 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/10 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Investigations
Gamma-glutamyltransferase increased
|
10.0%
1/10 • Number of events 1 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/10 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/10 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/10 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
0.00%
0/10 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
10.0%
1/10 • Number of events 1 • from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60