Trial Outcomes & Findings for AflacLL1901 (CHOA-AML) (NCT NCT04326439)
NCT ID: NCT04326439
Last Updated: 2022-06-15
Results Overview
Event-free survival defined as the time from on study to death, failure to achieve remission or relapse in newly diagnosed patients with pediatric acute myeloid leukemia in the Low risk stratification group and High risk stratification group
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Up to 2 years post-intervention
Results posted on
2022-06-15
Participant Flow
Participant milestones
| Measure |
Aflac-AML Low Risk Patients
Patients were classified as low risk following Induction I. All were MRD negative without low or high risk genetic and prognostic factors.
* Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype
* Induction II: Mitoxantrone/AraC
* Intensification I: AraC/Etoposide
* Intensification II: HD AraC/Asparaginase
|
Aflac-AML High Risk Patients
Patients were classified as high risk following Induction I. All were MRD negative with high risk genetic and prognostic factors.
Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype\^ Induction II: Mitoxantrone/AraC\^ Intensification:\* AraC/Etoposide\^ OR HD AraC/Asparaginase\^ Allogenic HSCT
* \^If has FLT3-ITD mutation, Sorafenib is added
* \* Depending on timing patients may proceed to HSCT following Induction II or receive Intensification. If HSCT is not an option, patients can receive 4 cycles of chemotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Aflac-AML Low Risk Patients
Patients were classified as low risk following Induction I. All were MRD negative without low or high risk genetic and prognostic factors.
* Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype
* Induction II: Mitoxantrone/AraC
* Intensification I: AraC/Etoposide
* Intensification II: HD AraC/Asparaginase
|
Aflac-AML High Risk Patients
Patients were classified as high risk following Induction I. All were MRD negative with high risk genetic and prognostic factors.
Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype\^ Induction II: Mitoxantrone/AraC\^ Intensification:\* AraC/Etoposide\^ OR HD AraC/Asparaginase\^ Allogenic HSCT
* \^If has FLT3-ITD mutation, Sorafenib is added
* \* Depending on timing patients may proceed to HSCT following Induction II or receive Intensification. If HSCT is not an option, patients can receive 4 cycles of chemotherapy
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Proceeded to HSCT after Induction 2
|
0
|
2
|
|
Overall Study
Relapse after Induction 2
|
0
|
1
|
|
Overall Study
Refractory CNS Leukemia after 6 doses IT cytarabine
|
1
|
0
|
Baseline Characteristics
AflacLL1901 (CHOA-AML)
Baseline characteristics by cohort
| Measure |
Aflac-AML Low Risk Patients
n=5 Participants
Patients were classified as low risk following Induction I. All were MRD negative without low or high risk genetic and prognostic factors.
* Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype
* Induction II: Mitoxantrone/AraC
* Intensification I: AraC/Etoposide
* Intensification II: HD AraC/Asparaginase
|
Aflac-AML High Risk Patients
n=3 Participants
Patients were classified as high risk following Induction I. All were MRD negative with high risk genetic and prognostic factors.
Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype\^ Induction II: Mitoxantrone/AraC\^ Intensification:\* AraC/Etoposide\^ OR HD AraC/Asparaginase\^ Allogenic HSCT
* \^If has FLT3-ITD mutation, Sorafenib is added
* \* Depending on timing patients may proceed to HSCT following Induction II or receive Intensification. If HSCT is not an option, patients can receive 4 cycles of chemotherapy
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
1.8 years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
4.1 years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
2.7 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years post-interventionEvent-free survival defined as the time from on study to death, failure to achieve remission or relapse in newly diagnosed patients with pediatric acute myeloid leukemia in the Low risk stratification group and High risk stratification group
Outcome measures
| Measure |
Aflac-AML Low Risk Patients
n=5 Participants
Patients were classified as low risk following Induction I. All were MRD negative without low or high risk genetic and prognostic factors.
* Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype
* Induction II: Mitoxantrone/AraC
* Intensification I: AraC/Etoposide
* Intensification II: HD AraC/Asparaginase
|
Aflac-AML High Risk Patients
n=3 Participants
Patients were classified as high risk following Induction I. All were MRD negative with high risk genetic and prognostic factors.
Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype\^ Induction II: Mitoxantrone/AraC\^ Intensification:\* AraC/Etoposide\^ OR HD AraC/Asparaginase\^ Allogenic HSCT
* \^If has FLT3-ITD mutation, Sorafenib is added
* \* Depending on timing patients may proceed to HSCT following Induction II or receive Intensification. If HSCT is not an option, patients can receive 4 cycles of chemotherapy
|
|---|---|---|
|
Event-free Survival (EFS) in Low Risk Patients and High Risk Patients
|
1.20 years
Interval 0.16 to
Insufficient number of participants with events; maximum observation was censored at last follow-up.
|
0.76 years
Interval 0.23 to
Insufficient number of participants with events; maximum observation was censored at last follow-up.
|
SECONDARY outcome
Timeframe: Up to 2 years post-interventionTime from study entry and from end of first course of therapy for newly diagnosed patients with pediatric acute myeloid leukemia
Outcome measures
| Measure |
Aflac-AML Low Risk Patients
n=5 Participants
Patients were classified as low risk following Induction I. All were MRD negative without low or high risk genetic and prognostic factors.
* Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype
* Induction II: Mitoxantrone/AraC
* Intensification I: AraC/Etoposide
* Intensification II: HD AraC/Asparaginase
|
Aflac-AML High Risk Patients
n=3 Participants
Patients were classified as high risk following Induction I. All were MRD negative with high risk genetic and prognostic factors.
Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype\^ Induction II: Mitoxantrone/AraC\^ Intensification:\* AraC/Etoposide\^ OR HD AraC/Asparaginase\^ Allogenic HSCT
* \^If has FLT3-ITD mutation, Sorafenib is added
* \* Depending on timing patients may proceed to HSCT following Induction II or receive Intensification. If HSCT is not an option, patients can receive 4 cycles of chemotherapy
|
|---|---|---|
|
Overall Survival (OS)
|
1.97 years
Interval 0.36 to
Insufficient number of participants with events; maximum observation was censored at last follow-up
|
1.98 years
Interval 0.21 to
Insufficient number of participants with events; maximum observation was censored at last follow-up
|
SECONDARY outcome
Timeframe: Post-induction I, an average of 28 daysNumber of patients that are in remission (MRD negative) after course 1 in participants receiving GO and those that did not receive GO.
Outcome measures
| Measure |
Aflac-AML Low Risk Patients
n=5 Participants
Patients were classified as low risk following Induction I. All were MRD negative without low or high risk genetic and prognostic factors.
* Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype
* Induction II: Mitoxantrone/AraC
* Intensification I: AraC/Etoposide
* Intensification II: HD AraC/Asparaginase
|
Aflac-AML High Risk Patients
n=3 Participants
Patients were classified as high risk following Induction I. All were MRD negative with high risk genetic and prognostic factors.
Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype\^ Induction II: Mitoxantrone/AraC\^ Intensification:\* AraC/Etoposide\^ OR HD AraC/Asparaginase\^ Allogenic HSCT
* \^If has FLT3-ITD mutation, Sorafenib is added
* \* Depending on timing patients may proceed to HSCT following Induction II or receive Intensification. If HSCT is not an option, patients can receive 4 cycles of chemotherapy
|
|---|---|---|
|
Minimal Residual Disease (MRD) Negative Status
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years post-interventionPopulation: All patients were MRD negative at the end of Induction I. No patients were assigned low risk due to low risk molecular and cytogenetic features. All high risk patients had high risk molecular and cytogenetic features.
Disease-free survival for patients who are MRD negative but lack high or low risk molecular and cytogenetic features, defined as time from end of first course of therapy to death or relapse
Outcome measures
| Measure |
Aflac-AML Low Risk Patients
n=5 Participants
Patients were classified as low risk following Induction I. All were MRD negative without low or high risk genetic and prognostic factors.
* Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype
* Induction II: Mitoxantrone/AraC
* Intensification I: AraC/Etoposide
* Intensification II: HD AraC/Asparaginase
|
Aflac-AML High Risk Patients
Patients were classified as high risk following Induction I. All were MRD negative with high risk genetic and prognostic factors.
Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype\^ Induction II: Mitoxantrone/AraC\^ Intensification:\* AraC/Etoposide\^ OR HD AraC/Asparaginase\^ Allogenic HSCT
* \^If has FLT3-ITD mutation, Sorafenib is added
* \* Depending on timing patients may proceed to HSCT following Induction II or receive Intensification. If HSCT is not an option, patients can receive 4 cycles of chemotherapy
|
|---|---|---|
|
Disease-free Survival (DFS) for Patients Who Are MRD Negative
|
1.08 years
Interval 0.04 to
Insufficient number of participants with events; maximum observation was censored at last follow-up.
|
—
|
SECONDARY outcome
Timeframe: At completion of Cycle 4 (each cycle average is 28 days)Population: The definition of late cardiotoxicity is after completion of therapy. All 3 of the high risk patients came off protocol early and did not complete therapy. For the low risk patients, 2 did not complete therapy. Among the 3 that did complete therapy, 1 patient has been lost to follow-up since completion of therapy with no cardiac data available.
Number of patients that develop cardiac ejection fraction \<50% (CTCAE V5.0 grade 2 or greater dysfunction) either during therapy (early cardiotoxicity) or after completion of therapy (late cardiotoxicity)
Outcome measures
| Measure |
Aflac-AML Low Risk Patients
n=5 Participants
Patients were classified as low risk following Induction I. All were MRD negative without low or high risk genetic and prognostic factors.
* Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype
* Induction II: Mitoxantrone/AraC
* Intensification I: AraC/Etoposide
* Intensification II: HD AraC/Asparaginase
|
Aflac-AML High Risk Patients
n=3 Participants
Patients were classified as high risk following Induction I. All were MRD negative with high risk genetic and prognostic factors.
Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype\^ Induction II: Mitoxantrone/AraC\^ Intensification:\* AraC/Etoposide\^ OR HD AraC/Asparaginase\^ Allogenic HSCT
* \^If has FLT3-ITD mutation, Sorafenib is added
* \* Depending on timing patients may proceed to HSCT following Induction II or receive Intensification. If HSCT is not an option, patients can receive 4 cycles of chemotherapy
|
|---|---|---|
|
Cardiotoxicity in Patients With de Novo AML That Receive the Four-cycle Aflac-AML Regimen With the Inclusion of Dexrazoxane
Early cardiotoxicity
|
0 Participants
|
0 Participants
|
|
Cardiotoxicity in Patients With de Novo AML That Receive the Four-cycle Aflac-AML Regimen With the Inclusion of Dexrazoxane
Late cardiotoxicity
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At the end of each cycle (each cycle average is 28 days)Population: All 3 of the high risk patients came off protocol early and did not complete therapy. For the low risk patients, 2 did not complete therapy. Among the 3 that did complete therapy, 1 patient has been lost to follow-up since completion of therapy with no cardiac data available.
Number of participants that developed infection and/or febrile neutropenia at the end of each treatment cycle.
Outcome measures
| Measure |
Aflac-AML Low Risk Patients
n=5 Participants
Patients were classified as low risk following Induction I. All were MRD negative without low or high risk genetic and prognostic factors.
* Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype
* Induction II: Mitoxantrone/AraC
* Intensification I: AraC/Etoposide
* Intensification II: HD AraC/Asparaginase
|
Aflac-AML High Risk Patients
n=3 Participants
Patients were classified as high risk following Induction I. All were MRD negative with high risk genetic and prognostic factors.
Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype\^ Induction II: Mitoxantrone/AraC\^ Intensification:\* AraC/Etoposide\^ OR HD AraC/Asparaginase\^ Allogenic HSCT
* \^If has FLT3-ITD mutation, Sorafenib is added
* \* Depending on timing patients may proceed to HSCT following Induction II or receive Intensification. If HSCT is not an option, patients can receive 4 cycles of chemotherapy
|
|---|---|---|
|
Proportion of Patients Who Develop Infection and/or Febrile Neutropenia During Each Treatment Course
Cycle 1 - Induction 1
|
5 Participants
|
2 Participants
|
|
Proportion of Patients Who Develop Infection and/or Febrile Neutropenia During Each Treatment Course
Cycle 2 - Induction 2
|
3 Participants
|
2 Participants
|
|
Proportion of Patients Who Develop Infection and/or Febrile Neutropenia During Each Treatment Course
Cycle 3 - Induction 3
|
2 Participants
|
0 Participants
|
|
Proportion of Patients Who Develop Infection and/or Febrile Neutropenia During Each Treatment Course
Cycle 4 - Induction 4
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At the end of each cycle (each cycle average is 28 days)Population: All 3 of the high risk patients came off protocol early and did not complete therapy. For the low risk patients, 2 did not complete therapy. Among the 3 that did complete therapy, 1 patient has been lost to follow-up since completion of therapy with no cardiac data available.
Duration of hospital admission in patients that developed infection and febrile neutropenia at the end of each treatment cycle
Outcome measures
| Measure |
Aflac-AML Low Risk Patients
n=5 Participants
Patients were classified as low risk following Induction I. All were MRD negative without low or high risk genetic and prognostic factors.
* Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype
* Induction II: Mitoxantrone/AraC
* Intensification I: AraC/Etoposide
* Intensification II: HD AraC/Asparaginase
|
Aflac-AML High Risk Patients
n=2 Participants
Patients were classified as high risk following Induction I. All were MRD negative with high risk genetic and prognostic factors.
Induction I: AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype\^ Induction II: Mitoxantrone/AraC\^ Intensification:\* AraC/Etoposide\^ OR HD AraC/Asparaginase\^ Allogenic HSCT
* \^If has FLT3-ITD mutation, Sorafenib is added
* \* Depending on timing patients may proceed to HSCT following Induction II or receive Intensification. If HSCT is not an option, patients can receive 4 cycles of chemotherapy
|
|---|---|---|
|
Duration of Hospital Admission in Patients That Developed Infection and Febrile Neutropenia at the End of Each Treatment Cycle
Cycle 1 - Induction 1
|
33 days
Standard Deviation 5.1
|
30 days
Standard Deviation 5.7
|
|
Duration of Hospital Admission in Patients That Developed Infection and Febrile Neutropenia at the End of Each Treatment Cycle
Cycle 2 - Induction 2
|
29.3 days
Standard Deviation 1.5
|
30.0 days
Standard Deviation 1.4
|
|
Duration of Hospital Admission in Patients That Developed Infection and Febrile Neutropenia at the End of Each Treatment Cycle
Cycle 3 - Induction 3
|
29 days
Standard Deviation 5.7
|
—
|
|
Duration of Hospital Admission in Patients That Developed Infection and Febrile Neutropenia at the End of Each Treatment Cycle
Cycle 4 - Induction 4
|
27.5 days
Standard Deviation 0.7
|
—
|
Adverse Events
Induction I
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Low Risk - Induction II
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
High Risk - Induction II
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Low Risk - Intensification I
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Low Risk - Intensification II
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Induction I
n=8 participants at risk
Participants in this group received AraC/Daunorubicin/Etoposide (10+3+5) +/- GO based on CC genotype\^ Patients were classified into risk groups following Induction I
* \^If has FLT3-ITD mutation, Sorafenib is added
|
Low Risk - Induction II
n=5 participants at risk
Participants in this group received Mitoxantrone/AraC
|
High Risk - Induction II
n=3 participants at risk
Participants in this group received Mitoxantrone/AraC\^
* \^If has FLT3-ITD mutation, Sorafenib is added
|
Low Risk - Intensification I
n=3 participants at risk
Participants in this group received AraC/Etoposide
|
Low Risk - Intensification II
n=3 participants at risk
Participants in this group received HD AraC/Asparaginase
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
62.5%
5/8 • Number of events 5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
80.0%
4/5 • Number of events 4 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
100.0%
3/3 • Number of events 3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
66.7%
2/3 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
66.7%
2/3 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Gastrointestinal disorders
Abdominal Pain
|
37.5%
3/8 • Number of events 3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Gastrointestinal disorders
Constipation
|
50.0%
4/8 • Number of events 4 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
3/8 • Number of events 3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
40.0%
2/5 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
100.0%
3/3 • Number of events 3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
4/8 • Number of events 4 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
40.0%
2/5 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
100.0%
3/3 • Number of events 3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
66.7%
2/3 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
66.7%
2/3 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
General disorders
Fever
|
100.0%
8/8 • Number of events 8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
40.0%
2/5 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
66.7%
2/3 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
100.0%
3/3 • Number of events 3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Infections and infestations
Sepsis
|
37.5%
3/8 • Number of events 3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
40.0%
2/5 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Injury, poisoning and procedural complications
Bruising
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Investigations
Alanine Aminotransferase Increased
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Investigations
Aspartate Aminotransferase Increased
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
40.0%
2/5 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Investigations
Blood Bilirubin Increased
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Investigations
Lipase increased
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Investigations
Lymphocyte Count Increased
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Investigations
Lymphocyte Count Decreased
|
25.0%
2/8 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
40.0%
2/5 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
66.7%
2/3 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
66.7%
2/3 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Investigations
Neutrophil count decreased
|
25.0%
2/8 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
40.0%
2/5 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
66.7%
2/3 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
66.7%
2/3 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Investigations
Platelet count decreased
|
75.0%
6/8 • Number of events 6 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
80.0%
4/5 • Number of events 4 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
66.7%
2/3 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
100.0%
3/3 • Number of events 3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
100.0%
3/3 • Number of events 3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Investigations
White Blood Cell Decreased
|
25.0%
2/8 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
40.0%
2/5 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
66.7%
2/3 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
66.7%
2/3 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Investigations
Weight loss
|
37.5%
3/8 • Number of events 3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Anorexia
|
62.5%
5/8 • Number of events 5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
40.0%
2/5 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
66.7%
2/3 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
66.7%
2/3 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
2/8 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
40.0%
2/5 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
2/8 • Number of events 3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Psychiatric disorders
Agitation
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Psychiatric disorders
Hallucinations
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Psychiatric disorders
Irritability
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
2/8 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
2/8 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
40.0%
2/5 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
66.7%
2/3 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Vascular disorders
Hypotension
|
25.0%
2/8 • Number of events 2 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
20.0%
1/5 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
0.00%
0/8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Vascular disorders
Hematoma
|
0.00%
0/8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Investigations
Alkaline Phosphatase Increased
|
0.00%
0/8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/8 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/5 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
0.00%
0/3 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
33.3%
1/3 • Number of events 1 • Time of consent through end of follow-up (Up to 2 years post-intervention).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place