Trial Outcomes & Findings for WTX-330 in Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma (NCT NCT05678998)
NCT ID: NCT05678998
Last Updated: 2026-01-06
Results Overview
A DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle of treatment with WTX-330 and meets any of the criteria included in the protocol
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
4 weeks
Results posted on
2026-01-06
Participant Flow
Participants were recruited based on their oncological history at 9 clinical research sites in the United States.
36 potential participants underwent screening, 11 were screened out, and 25 were included in the trial.
Participant milestones
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A); 0.024 mg/kg
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen. Expansion Dose was 0.024 mg/kg.
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B); 0.024 mg/kg
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved. Expansion Dose was 0.024 mg/kg.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
5
|
5
|
9
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
5
|
7
|
Reasons for withdrawal
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A); 0.024 mg/kg
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen. Expansion Dose was 0.024 mg/kg.
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B); 0.024 mg/kg
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved. Expansion Dose was 0.024 mg/kg.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
3
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
3
|
4
|
|
Overall Study
Other
|
0
|
0
|
0
|
2
|
1
|
Baseline Characteristics
WTX-330 in Patients With Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A); 0.024 mg/kg
n=5 Participants
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B); 0.024 mg/kg
n=9 Participants
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=5 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 10.26 • n=37 Participants
|
60.6 years
STANDARD_DEVIATION 11.55 • n=56 Participants
|
68.2 years
STANDARD_DEVIATION 7.90 • n=82 Participants
|
65.00 years
STANDARD_DEVIATION 11.00 • n=31 Participants
|
61.8 years
STANDARD_DEVIATION 10.13 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 9.44 • n=25 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=37 Participants
|
2 Participants
n=56 Participants
|
5 Participants
n=82 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=37 Participants
|
3 Participants
n=56 Participants
|
4 Participants
n=82 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=37 Participants
|
5 Participants
n=56 Participants
|
8 Participants
n=82 Participants
|
3 Participants
n=31 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=37 Participants
|
5 Participants
n=56 Participants
|
9 Participants
n=82 Participants
|
2 Participants
n=31 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: 4 weeksA DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle of treatment with WTX-330 and meets any of the criteria included in the protocol
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=5 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Incidence of Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Safety Analysis Set included all participants
AEs were graded and documented in accordance with NCI-CTCAE version 5.0
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=5 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
n=5 Participants
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
n=9 Participants
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Incidence of Treatment Emergent Adverse Events
Grade 3 or Higher TEAEs
|
1 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
|
Incidence of Treatment Emergent Adverse Events
Grade 3 or Higher TEAEs Related to WTX-330
|
1 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
|
Incidence of Treatment Emergent Adverse Events
Serious TEAEs
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
|
Incidence of Treatment Emergent Adverse Events
Serious TEAEs Related to WTX-330
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Incidence of Treatment Emergent Adverse Events
TEAE
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
9 Participants
|
|
Incidence of Treatment Emergent Adverse Events
TEAEs Related to WTX-330
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 24 monthsChange from baseline is provided as baseline grade or "normal/low/high" and worst post-baseline grade.
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=5 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
n=5 Participants
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
n=9 Participants
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 0 - Grade 0
|
3 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
9 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 0 - Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypermagnesemia · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 0 - Grade 0
|
2 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
9 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 0 - Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 0 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 0 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 0 - Grade 0
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 0 - Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 1 - Grade 1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 0 - Grade 0
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 0 - Grade 1
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 0 - Grade 0
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 0 - Grade 1
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Normal - Grade 1
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · High - Grade 0
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Normal - Grade 0
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Normal - Grade 1
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 0 - Grade 0
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 0 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 0 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 0 - Grade 1
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 1 - Grade 1
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 1 - Grade 2
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 1 - Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Anemia · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypernatremia · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 0 - Grade 0
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 0 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 0 - Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 2 - Grade 2
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
INR increased · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 0 - Grade 0
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
9 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 0 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count increased · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 0 - Grade 0
|
3 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 0 - Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoglycemia · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 0 - Grade 0
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 0 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 0 - Grade 2
|
0 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 2 - Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 2 - Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 0 - Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypoalbuminemia · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 0 - Grade 0
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 0 - Grade 1
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 0 - Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 1 - Grade 0
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyponatremia · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 0 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 0 - Grade 3
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 1 - Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 2 - Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Lymphocyte count decreased · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 0 - Grade 0
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 1 - Grade 2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Platelet count decreased · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 0 - Grade 0
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 0 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 0 - Grade 2
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 0 - Grade 3
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypokalemia · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 0 - Grade 0
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 0 - Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 1 - Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hypomagnesemia · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 0 - Grade 0
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 0 - Grade 1
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 0 - Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Normal - Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
GGT increased · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 0 - Grade 0
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
9 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 0 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
White blood cell decreased · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 0 - Grade 0
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 0 - Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 0 - Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 1 - Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Normal - Grade 0
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Normal - Grade 1
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Normal - Grade 2
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Normal - Grade 0
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hyperkalemia · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 0 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 0 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Normal - Grade 0
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Normal - Grade 1
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · Normal - Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · High - Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alkaline phosphatase increased · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 0 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 0 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Low - Grade 0
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · Normal - Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · High - Grade 1
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Aspartate aminotransferase increased · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 0 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 0 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 0 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 0 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 2 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · High - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · High - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · High - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Hemoglobin increased · High - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 1 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 1 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 1 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 1 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 2 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 2 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 2 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 2 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 3 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 3 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 3 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 3 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 4 - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 4 - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 4 - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 0 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 1 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Grade 3 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Blood bilirubin increased · Low - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Alanine aminotransferase increased · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Normal - Grade 0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Normal - Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Normal - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Activated partial thromboplastin time prolonged · Normal - Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 4 - Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Changes in Clinical Laboratory Abnormalities
Creatinine increased · Grade 4 - Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: The overall number of participants analyzed is lower than the overall study population, as the efficacy evaluable analysis set does not include all enrolled participants
RECIST = Response Evaluation Criteria in Solid Tumors
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
n=5 Participants
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
n=7 Participants
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Investigator-assessed Objective Response Rate (ORR) by RECIST 1.1 and Immune ORR by iRECIST (for Solid Tumors) or Response by Lugano Criteria (for Lymphomas)
ORR by RECIST
|
0 Percent of participants
Interval 0.0 to 70.8
|
33.3 Percent of participants
Interval 0.8 to 90.6
|
0 Percent of participants
Interval 0.0 to 70.8
|
0 Percent of participants
Interval 0.0 to 52.2
|
0 Percent of participants
Interval 0.0 to 41.0
|
|
Investigator-assessed Objective Response Rate (ORR) by RECIST 1.1 and Immune ORR by iRECIST (for Solid Tumors) or Response by Lugano Criteria (for Lymphomas)
immune ORR by iRECIST
|
0 Percent of participants
Interval 0.0 to 70.8
|
33.3 Percent of participants
Interval 0.8 to 90.6
|
0 Percent of participants
Interval 0.0 to 70.8
|
0 Percent of participants
Interval 0.0 to 52.2
|
0 Percent of participants
Interval 0.0 to 41.0
|
SECONDARY outcome
Timeframe: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1Population: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms.
PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=5 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of WTX-330 Cycle 1 - C Max
|
0.2773 mcg/ml
Standard Deviation 0.11684
|
0.4290 mcg/ml
Standard Deviation 0.29465
|
0.8624 mcg/ml
Standard Deviation 0.17688
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1Population: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms.
PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=5 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of WTX-330 Cycle 1 - Time of Maximum Concentration Observation
|
2.40 h
Standard Deviation 3.637
|
2.93 h
Standard Deviation 4.561
|
3.26 h
Standard Deviation 1.668
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1Population: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms.
PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=5 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of WTX-330 Cycle 1 - Half Life
|
2.1886 day
Standard Deviation 1.23394
|
2.7083 day
Standard Deviation 1.00754
|
3.3463 day
Standard Deviation 1.48342
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms.
PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose.
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=5 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of WTX-330 Cycle 1 - AUC
|
0.7585 day*mcg/ml
Standard Deviation 0.50363
|
1.1952 day*mcg/ml
Standard Deviation 0.84243
|
1.7270 day*mcg/ml
Standard Deviation 0.75076
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2Population: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available.
PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=2 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=4 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of WTX-330 Cycle 2 - C Max
|
0.3210 mcg/ml
Standard Deviation 0.04950
|
0.6272 mcg/ml
Standard Deviation 0.60613
|
1.0748 mcg/ml
Standard Deviation 0.70201
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2Population: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available.
PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=2 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=4 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of WTX-330 Cycle 2 - Time of Maximum Concentration Observation
|
0.30 h
Standard Deviation 0
|
1.40 h
Standard Deviation 1.992
|
2.15 h
Standard Deviation 2.136
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2Population: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available.
PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=2 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=4 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of WTX-330 Cycle 2 - Half Life
|
3.3296 day
Standard Deviation 0.34454
|
2.8809 day
Standard Deviation 1.73910
|
4.0216 day
Standard Deviation 1.06686
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available.
PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose.
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=2 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=4 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of WTX-330 Cycle 2 - AUC
|
1.0247 day*mcg/ml
Standard Deviation 0.14275
|
0.8744 day*mcg/ml
Standard Deviation 0.51499
|
1.8042 day*mcg/ml
Standard Deviation 0.80145
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1Population: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms.
PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=5 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of IL-12 Cycle 1 - C Max
|
1434.7 pg/ml
Standard Deviation 694.10
|
2298.0 pg/ml
Standard Deviation 1434.71
|
3022.0 pg/ml
Standard Deviation 787.48
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1Population: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms.
PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=5 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of IL-12 Cycle 1 - Time of Maximum Concentration Observation
|
4.90 h
Standard Deviation 1.473
|
5.23 h
Standard Deviation 2.065
|
6.48 h
Standard Deviation 2.182
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1Population: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms.
PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 1
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=5 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of IL-12 Cycle 1 - Half Life
|
3.2138 day
Standard Deviation 1.33405
|
3.2643 day
Standard Deviation 1.26642
|
2.4809 day
Standard Deviation 0.75436
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms.
PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose.
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=5 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of IL-12 Cycle 1 - AUC
|
3221.5 day*pg/ml
Standard Deviation 1879.29
|
5144.7 day*pg/ml
Standard Deviation 3395.29
|
5986.4 day*pg/ml
Standard Deviation 2336.59
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2Population: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available.
PK described by maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=2 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=4 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of IL-12 Cycle 2 - C Max
|
1331.5 pg/ml
Standard Deviation 26.16
|
2165.7 pg/ml
Standard Deviation 1933.23
|
3292.8 pg/ml
Standard Deviation 2236.70
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2Population: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available.
PK described by time to maximum concentration. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=2 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=4 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of IL-12 Cycle 2 - Time of Maximum Concentration Observation
|
13.80 h
Standard Deviation 13.435
|
0.27 h
Standard Deviation 0.058
|
2.95 h
Standard Deviation 1.782
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2Population: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available.
PK described by Half-Life Lambda z. Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose on Day 1 of Cycle 2
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=2 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=4 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of IL-12 Cycle 2 - Half Life
|
2.2540 day
Standard Deviation 0.92905
|
3.8541 day
Standard Deviation 0.92348
|
2.7120 day
Standard Deviation 1.54085
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Comprehensive PK was only assessed for the dose-escalation arms. Therefore, only the 3 dose-escalation arms are represented in these analyses, and not the two expansion arms. Overall Number of Participants Analyzed is lower for cycle 2, as not all participants continued on study and not all samples were available.
PK described by Area Under Curve (0-14 day). Sample collection timepoints: 0, 4, 8, 24, 48, and 168 hours post-dose.
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=2 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=4 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Plasma Concentrations of IL-12 Cycle 2 - AUC
|
3569.4 day*pg/ml
Standard Deviation 636.45
|
1957.5 day*pg/ml
Standard Deviation 635.67
|
4349.9 day*pg/ml
Standard Deviation 1530.39
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 monthsADA were measured at Baseline and Post Baseline. "Positive" post baseline applies if at least one post-baseline value was positive.
Outcome measures
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=5 Participants
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A)
n=5 Participants
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B)
n=9 Participants
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Antidrug Antibody (ADA) Occurrence
ADA at Baseline · Negative
|
2 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
|
Antidrug Antibody (ADA) Occurrence
ADA at Baseline · Positive
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Antidrug Antibody (ADA) Occurrence
ADA at Baseline · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Antidrug Antibody (ADA) Occurrence
ADA post Baseline · Negative
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Antidrug Antibody (ADA) Occurrence
ADA post Baseline · Positive
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Antidrug Antibody (ADA) Occurrence
ADA post Baseline · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
Adverse Events
WTX-330 Dose Escalation - 0.016 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
WTX-330 Dose Escalation - 0.024 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
WTX-330 Dose Escalation - 0.032 mg/kg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A); 0.024 mg/kg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 3 deaths
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B); 0.024 mg/kg
Serious events: 8 serious events
Other events: 9 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 participants at risk
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 participants at risk
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=5 participants at risk
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A); 0.024 mg/kg
n=5 participants at risk
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B); 0.024 mg/kg
n=9 participants at risk
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
22.2%
2/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
44.4%
4/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma of sites other than skin
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
22.2%
2/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
Other adverse events
| Measure |
WTX-330 Dose Escalation - 0.016 mg/kg
n=3 participants at risk
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.016 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.024 mg/kg
n=3 participants at risk
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.024 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Escalation - 0.032 mg/kg
n=5 participants at risk
Patients with relapsed/refractory advanced or metastatic solid tumors received a dose of 0.032 mg/kg on Days 1 and 15 (i.e., every 2 weeks, Q2W) of 28-day treatment cycle
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Indicated (Arm A); 0.024 mg/kg
n=5 participants at risk
WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen
|
WTX-330 Dose Expansion in Patients for Whom CPI Therapy is Not Indicated (Arm B); 0.024 mg/kg
n=9 participants at risk
WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved
|
|---|---|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
General disorders
Asthenia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
22.2%
2/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
3/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
General disorders
Chills
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
80.0%
4/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
66.7%
6/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
44.4%
4/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
22.2%
2/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
66.7%
2/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
3/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
22.2%
2/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
100.0%
5/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
3/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
66.7%
2/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
44.4%
4/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
General disorders
Fatigue
|
66.7%
2/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
66.7%
2/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
60.0%
3/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
3/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
General disorders
Pyrexia
|
66.7%
2/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
60.0%
3/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
60.0%
3/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
44.4%
4/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Immune system disorders
Cytokine release syndrome
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
66.7%
2/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
60.0%
3/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
22.2%
2/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Infections and infestations
Cystitis
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
60.0%
3/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
44.4%
4/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
Ammonia increased
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
60.0%
3/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
44.4%
4/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
3/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
Cortisol decreased
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
60.0%
3/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
Respiratory rate increased
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
22.2%
2/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
60.0%
3/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
55.6%
5/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Metabolism and nutrition disorders
Dehydration
|
66.7%
2/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
3/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
60.0%
3/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
22.2%
2/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
22.2%
2/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
44.4%
4/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
66.7%
2/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
22.2%
2/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma of sites other than skin
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Nervous system disorders
Sinus headache
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
22.2%
2/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
22.2%
2/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Reproductive system and breast disorders
Testicular swelling
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
3/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Surgical and medical procedures
Wound drainage
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
20.0%
1/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
66.7%
2/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
3/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
33.3%
1/3 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
40.0%
2/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
0.00%
0/5 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
11.1%
1/9 • AEs were collected from the signing of the ICF for a median duration of 86 days (min 37, max 219)
All AEs were graded and documented in accordance with NCI-CTCAE version 5.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place