Trial Outcomes & Findings for Eltanexor (KPT-8602) With Inqovi (Decitabine-Cedazuridine) in High-Risk Myelodysplastic Syndromes (NCT NCT05918055)
NCT ID: NCT05918055
Last Updated: 2025-12-02
Results Overview
If no DLTs are observed at the highest planned dose level for evaluation (dose level 2), dose escalation will stop, and this will be considered the recommended phase 2 dose (RP2D) of Eltanexor (KPT-8602). A DLT is defined as a treatment-related toxicity based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
From day 1 of study drug through 28 days after the first dose
Results posted on
2025-12-02
Participant Flow
All (#3) participants enrolled in this study are counted. 1/3 participants were deemed ineligible after consent was signed to participate in the study. Baseline data for this participant was collected and reported. All participants that started Dose Level 1 were de-escalated to Dose Level -1
Participant milestones
| Measure |
Phase I - Dose escalation of Eltanexor (KPT-8602) for High-Risk Myelodysplastic Syndromes
Inqovi for 5 days, followed by escalating doses of Eltanexor (KPT-8602)
KPT-8602: 5-10 mg by mouth (PO) daily for 10-14 days based on dose level
Inqovi: Inqovi will be administered via oral route once daily on Days 1-5 of each treatment cycle, according to guidelines outlined in the Food and Drug Administration (FDA) product label.
|
Phase II - Dose expansion for High-Risk Myelodysplastic Syndromes
Inqovi for 5 days, followed by recommended phase 2 dose (RP2D)/Phase II dose of Eltanexor (KPT-8602)
KPT-8602: 5-10 mg by mouth (PO) daily for 10-14 days based on dose level
Inqovi: Inqovi will be administered via oral route once daily on Days 1-5 of each treatment cycle, according to guidelines outlined in the Food and Drug Administration (FDA) product label.
|
Participant Enrolled But Not Treated
Participant was enrolled but not treated.
|
|---|---|---|---|
|
Phase I - Dose Level 1
STARTED
|
2
|
0
|
1
|
|
Phase I - Dose Level 1
COMPLETED
|
2
|
0
|
0
|
|
Phase I - Dose Level 1
NOT COMPLETED
|
0
|
0
|
1
|
|
Phase I - Dose Level -1
STARTED
|
2
|
0
|
0
|
|
Phase I - Dose Level -1
COMPLETED
|
1
|
0
|
0
|
|
Phase I - Dose Level -1
NOT COMPLETED
|
1
|
0
|
0
|
|
Phase II
STARTED
|
0
|
0
|
0
|
|
Phase II
COMPLETED
|
0
|
0
|
0
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I - Dose escalation of Eltanexor (KPT-8602) for High-Risk Myelodysplastic Syndromes
Inqovi for 5 days, followed by escalating doses of Eltanexor (KPT-8602)
KPT-8602: 5-10 mg by mouth (PO) daily for 10-14 days based on dose level
Inqovi: Inqovi will be administered via oral route once daily on Days 1-5 of each treatment cycle, according to guidelines outlined in the Food and Drug Administration (FDA) product label.
|
Phase II - Dose expansion for High-Risk Myelodysplastic Syndromes
Inqovi for 5 days, followed by recommended phase 2 dose (RP2D)/Phase II dose of Eltanexor (KPT-8602)
KPT-8602: 5-10 mg by mouth (PO) daily for 10-14 days based on dose level
Inqovi: Inqovi will be administered via oral route once daily on Days 1-5 of each treatment cycle, according to guidelines outlined in the Food and Drug Administration (FDA) product label.
|
Participant Enrolled But Not Treated
Participant was enrolled but not treated.
|
|---|---|---|---|
|
Phase I - Dose Level 1
Ineligible
|
0
|
0
|
1
|
|
Phase I - Dose Level -1
Physician Decision
|
1
|
0
|
0
|
Baseline Characteristics
Eltanexor (KPT-8602) With Inqovi (Decitabine-Cedazuridine) in High-Risk Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
Phase I - Dose Escalation of Eltanexor (KPT-8602) for High-Risk Myelodysplastic Syndromes
n=2 Participants
Inqovi for 5 days, followed by escalating doses of Eltanexor (KPT-8602)
KPT-8602: 5-10 mg by mouth (PO) daily for 10-14 days based on dose level
Inqovi: Inqovi will be administered via oral route once daily on Days 1-5 of each treatment cycle, according to guidelines outlined in the Food and Drug Administration (FDA) product label.
|
Participant Enrolled But Not Treated
n=1 Participants
Participant was enrolled but not treated.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 16.26 • n=121 Participants
|
81 years
STANDARD_DEVIATION 0 • n=122 Participants
|
56.67 years
STANDARD_DEVIATION 24.01 • n=243 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Ethnicity - Hispanic or Latino
|
2 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Ethnicity - Not Hispanic or Latino
|
0 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Ethnicity - Unknown or Not Reported
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race - American Indian or Alaska Native
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race - Asian
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race -Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race - Black or African American
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race - White
|
0 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race - Unknown or Not Reported
|
1 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Race - Other
|
1 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=243 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=121 Participants
|
1 participants
n=122 Participants
|
3 participants
n=243 Participants
|
PRIMARY outcome
Timeframe: From day 1 of study drug through 28 days after the first dosePopulation: 2/3 participants were analyzed because the 2 participants that started in Dose Level 1, also de-escalated and treated on Dose Level -1. And 1 participant were not treated in Dose Level 1 or Dose Level-1 because they were not eligible for the study.
If no DLTs are observed at the highest planned dose level for evaluation (dose level 2), dose escalation will stop, and this will be considered the recommended phase 2 dose (RP2D) of Eltanexor (KPT-8602). A DLT is defined as a treatment-related toxicity based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Outcome measures
| Measure |
Phase I:Dose escalation of Eltanexor(KPT-8602) for High-Risk Myelodysplastic Syndromes-Dose Level -1
Participants with confirmed Myelodysplastic Syndromes and International Prognostic Scoring System (IPSS-R) score \>3.5 (high and higher intermediate-risk).
Dose level -1: Ingovi (Decitabine-Cedazuridine), 1 tablet orally once daily on Days 1-4. Eltanexor (KPT-8602) 5 mg by mouth (PO) daily on Days 8-21.
|
All Participants in Phase I
n=2 Participants
All participants in phase I who received at least 9/10 doses of Eltanexor (KPT-8602) and 4/5 doses of Ingovi (Decitabine-Cedazuridine) within the DLT period.
|
Participant Enrolled But Not Treated
Participant was enrolled but not treated.
|
|---|---|---|---|
|
Phase 1: Recommended Phase 2 Dose (RP2D) of Eltanexor (KPT-8602) in Combination With Inqovi (Decitabine-Cedazuridine) in Adult Participants With Higher-Myelodysplastic Syndromes (MDS)
|
—
|
NA mg
The RP2D was not found because the number of participants accrued was inadequate to establish a RP2D.
|
—
|
PRIMARY outcome
Timeframe: First 28 days of study treatmentPopulation: 2/3 participants were analyzed because one participant was enrolled but not treated.
Participants enrolled in phase I will have the grades and types of toxicity reported at each dose level to determine the RP2D. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event. Toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Outcome measures
| Measure |
Phase I:Dose escalation of Eltanexor(KPT-8602) for High-Risk Myelodysplastic Syndromes-Dose Level -1
n=2 Participants
Participants with confirmed Myelodysplastic Syndromes and International Prognostic Scoring System (IPSS-R) score \>3.5 (high and higher intermediate-risk).
Dose level -1: Ingovi (Decitabine-Cedazuridine), 1 tablet orally once daily on Days 1-4. Eltanexor (KPT-8602) 5 mg by mouth (PO) daily on Days 8-21.
|
All Participants in Phase I
n=2 Participants
All participants in phase I who received at least 9/10 doses of Eltanexor (KPT-8602) and 4/5 doses of Ingovi (Decitabine-Cedazuridine) within the DLT period.
|
Participant Enrolled But Not Treated
Participant was enrolled but not treated.
|
|---|---|---|---|
|
Phase 1: Number of Participants Who Have Grades 3 and/or 4 Dose-limiting Toxicity (DLT) at the Recommended Phase 2 Dose (RP2D)
Grade 4 Neutrophil Count Decreased
|
0 Participants
|
1 Participants
|
—
|
|
Phase 1: Number of Participants Who Have Grades 3 and/or 4 Dose-limiting Toxicity (DLT) at the Recommended Phase 2 Dose (RP2D)
Grade 3 Platelet Count Decreased
|
0 Participants
|
1 Participants
|
—
|
|
Phase 1: Number of Participants Who Have Grades 3 and/or 4 Dose-limiting Toxicity (DLT) at the Recommended Phase 2 Dose (RP2D)
Grade 4 Platelet Count Decreased
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Each cycle (bloods), cycle 2 and 6 during treatment and every 3-6 months (bloods and bone marrow)Population: This outcome was not done because no participants accrued on phase 2.
Participants evaluated in phase II will have the fraction with clinical responses reported, with a 95% confidence interval. ORR is defined as Complete Remission (CR)+Partial Remission (PR)+marrow (mCR) with hematologic improvement (HI) per each cohort and assessed by the 2006 International Working Group Response Criteria with Modified Definitions for Hematologic Improvement by the 2018 International Working Group Response Criteria. Complete Remission (CR) is bone marrow: ≤5% myeloblasts with normal maturation of all cell lines. Partial Remission (PR) is all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pretreatment but still \>5%; and cellularity and morphology not relevant. Marrow Complete Remission is bone marrow: ≤5% myeloblasts and decrease by ≥50% over pretreatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1, 2, 3, 4, 8, 24 and 48 hours after the product administration on days 8 and 21 of cycle onePopulation: Data was not analyzed and reported because samples collected are insufficient to complete analysis. Since 2 participants were accrued to study this drug has been removed from analysis by the drug company. No further studies are becoming completed, and the samples will not be analyzed in the future.
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1, 2, 3, 4, 8, 24 and 48 hours after the product administration on days 8 and 21 of cycle onePopulation: Data was not analyzed and reported because samples collected are insufficient to complete analysis. Since 2 participants were accrued to study this drug has been removed from analysis by the drug company. No further studies are becoming completed, and the samples will not be analyzed in the future.
The half-life of Eltanexor (KPT-8602) will be evaluated in participants, by dose level when given in combination with Inqovi. Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1, 2, 3, 4, 8, 24 and 48 hours after the product administration on days 8 and 21 of cycle onePopulation: Data was not analyzed and reported because samples collected are insufficient to complete analysis. Since 2 participants were accrued to study this drug has been removed from analysis by the drug company. No further studies are becoming completed, and the samples will not be analyzed in the future.
Steady state concentration, measured by the Eltanexor (KPT-8602) blood concentration will be evaluated in participants, by dose level when given in combination with Inqovi (Decitabine-Cedazuridine). Steady state is defined as consistent drug concentration in the body.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At least weekly through cycle 3 and then at the start and every cycle after thatPopulation: This outcome was not done because no participants accrued on phase 2.
The grades and types of toxicity noted for the agent at each dose level will be reported. Toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At least weekly through cycle 3 and then at the start and every cycle after thatPopulation: This outcome was not done because no participants accrued on phase 2.
A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Serious adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Phase I:Dose escalation of Eltanexor(KPT-8602) for High-Risk Myelodysplastic Syndromes-Dose Level -1
n=2 Participants
Participants with confirmed Myelodysplastic Syndromes and International Prognostic Scoring System (IPSS-R) score \>3.5 (high and higher intermediate-risk).
Dose level -1: Ingovi (Decitabine-Cedazuridine), 1 tablet orally once daily on Days 1-4. Eltanexor (KPT-8602) 5 mg by mouth (PO) daily on Days 8-21.
|
All Participants in Phase I
n=2 Participants
All participants in phase I who received at least 9/10 doses of Eltanexor (KPT-8602) and 4/5 doses of Ingovi (Decitabine-Cedazuridine) within the DLT period.
|
Participant Enrolled But Not Treated
n=1 Participants
Participant was enrolled but not treated.
|
|---|---|---|---|
|
Phase 1: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
|
2 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
Outside Courses
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase I:Dose Escalation of Eltanexor (KPT-8602) for High-Risk Myelodysplastic Syndromes-Dose Level 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase I:Dose Escalation of Eltanexor(KPT-8602) for High-Risk Myelodysplastic Syndromes-Dose Level -1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Participant Enrolled But Not Treated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Outside Courses
n=1 participants at risk
One participant experienced 4 adverse events that occurred after Date Off Treatment (Outside Courses).
|
Phase I:Dose Escalation of Eltanexor (KPT-8602) for High-Risk Myelodysplastic Syndromes-Dose Level 1
n=2 participants at risk
Participants with confirmed Myelodysplastic Syndromes and International Prognostic Scoring System (IPSS-R) score \>3.5 (high and higher intermediate-risk).
Dose level 1: Ingovi (Decitabine-Cedazuridine), 1 tablet orally once daily on Days 1-5. Eltanexor (KPT-8602), 10 mg by mouth (PO) daily on Days 8-12 and Days 15-19.
|
Phase I:Dose Escalation of Eltanexor(KPT-8602) for High-Risk Myelodysplastic Syndromes-Dose Level -1
n=2 participants at risk
Participants with confirmed Myelodysplastic Syndromes and International Prognostic Scoring System (IPSS-R) score \>3.5 (high and higher intermediate-risk).
Dose level -1: Ingovi (Decitabine-Cedazuridine), 1 tablet orally once daily on Days 1-4. Eltanexor (KPT-8602) 5 mg by mouth (PO) daily on Days 8-21.
|
Participant Enrolled But Not Treated
n=1 participants at risk
Participant was enrolled but not treated.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
100.0%
2/2 • Number of events 10 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
100.0%
2/2 • Number of events 13 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 7 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
General disorders
Chills
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
100.0%
2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
100.0%
2/2 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
General disorders
Fatigue
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
General disorders
Fever
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify: Stomach discomfort after taking Deferasirox.
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
General disorders
General disorders and administration site conditions - Other, specify: Port occlusion
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Infections and infestations
Gum infection
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
100.0%
2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 6 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 7 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
General disorders
Malaise
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify: Hepatic steatosis
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
100.0%
1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: Stiffness
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
100.0%
2/2 • Number of events 13 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
100.0%
2/2 • Number of events 7 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
100.0%
2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
General disorders
Pain
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
100.0%
2/2 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Nervous system disorders
Paresthesia
|
100.0%
1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 6 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Burning sensation when urinating
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Nocturia (1-2 urinations per night)
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Polyuria
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: Polyuria, polydipsia
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/2 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Investigations
Weight loss
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
|
Investigations
White blood cell decreased
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
50.0%
1/2 • Number of events 10 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
100.0%
2/2 • Number of events 23 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
0.00%
0/1 • All-Cause Mortality was monitored/assessed an average of 8.5 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered, an average of 8.5 months.
Dosages on Dose Level -1 and Dose Level 1 were administered to participants during treatment. Start date is Start Date of 1st Course, cutoff date is Date Off Treatment. Adverse Events (AEs) can happen before treatment, during treatment and after treatment. Most of the AEs happened during the treatment in this study. There are only 4 Adverse Events for one participant which happened after Date Off Treatment (Outside Courses).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place