Trial Outcomes & Findings for Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation (NCT NCT01338987)
NCT ID: NCT01338987
Last Updated: 2021-03-18
Results Overview
B cell percentage is defined as the percentage of lymphocytes that are B cells.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
after first Bone Marrow Transplant, approximately 12 months post-transplant
Results posted on
2021-03-18
Participant Flow
Participant milestones
| Measure |
Males That Did Not Receive Leuprolide for 1st Transplant
Males undergoing first transplant who did not receive leuprolide.
|
Males Randomized to Receive Leuprolide for 1st Transplant
Males undergoing first transplant who were randomized to receive leuprolide.
|
Females That Received Leuprolide for 1st Transplant
Females undergoing first transplant who all received leuprolide.
|
Matched Related Donors for Transplant
Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic bone marrow transplant on this study.
|
Recipients of 2nd Transplant
Patients receiving second allogeneic bone marrow transplant on this study.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
22
|
31
|
2
|
|
Overall Study
COMPLETED
|
10
|
8
|
20
|
31
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Males That Did Not Receive Leuprolide for 1st Transplant
Males undergoing first transplant who did not receive leuprolide.
|
Males Randomized to Receive Leuprolide for 1st Transplant
Males undergoing first transplant who were randomized to receive leuprolide.
|
Females That Received Leuprolide for 1st Transplant
Females undergoing first transplant who all received leuprolide.
|
Matched Related Donors for Transplant
Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic bone marrow transplant on this study.
|
Recipients of 2nd Transplant
Patients receiving second allogeneic bone marrow transplant on this study.
|
|---|---|---|---|---|---|
|
Overall Study
enrolled on new protocol
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Disease progression on study
|
2
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation
Baseline characteristics by cohort
| Measure |
Males That Did Not Receive Leuprolide for 1st Transplant
n=12 Participants
Males undergoing first transplant who did not receive leuprolide.
|
Males Randomized to Receive Leuprolide for 1st Transplant
n=9 Participants
Males undergoing first transplant who were randomized to receive leuprolide.
|
Females That Received Leuprolide for 1st Transplant
n=22 Participants
Females undergoing first transplant who all received leuprolide.
|
Matched Related Donors for Transplant
n=31 Participants
Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic bone marrow transplant on this study.
|
Recipients of 2nd Transplant
n=2 Participants
Patients receiving second allogeneic Bone Marrow Transplant on this study.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
72 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 9.30 • n=5 Participants
|
26.77 years
STANDARD_DEVIATION 5.71 • n=7 Participants
|
36.05 years
STANDARD_DEVIATION 6.10 • n=5 Participants
|
33.86 years
STANDARD_DEVIATION 11.49 • n=4 Participants
|
23.05 years
STANDARD_DEVIATION 3.61 • n=21 Participants
|
33.61 years
STANDARD_DEVIATION 10.03 • n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
39 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
37 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
56 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
59 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
76 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: after first Bone Marrow Transplant, approximately 12 months post-transplantPopulation: Only first BMT patients (SG1-3) with \>1 year of follow-up without relapse were evaluable. Of evaluable patients, 5 males and 9 females received and 7 males did not receive Lupron. Reasons for patients being inevaluable were missing data (2) or insufficient follow-up due to death without relapse (3), relapse (11), or withdrawal (1) before 1 year.
B cell percentage is defined as the percentage of lymphocytes that are B cells.
Outcome measures
| Measure |
Transplant Recipient
n=21 Participants
Patients receiving first allogeneic bone marrow transplant on this study.
|
Males Randomized to Receive Leuprolide for 1st Transplant
Males undergoing first transplant who were randomized to receive leuprolide.
|
Females That Received Leuprolide for 1st Transplant
Females undergoing first transplant who all received leuprolide.
|
Matched Related Donors for Transplant
Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic Bone Marrow Transplant on this study.
|
Recipients of 2nd Transplant
Patients receiving second allogeneic Bone Marrow Transplant on this study.
|
|---|---|---|---|---|---|
|
Percentage of B Cells at One Year Post-transplant in Participants Who Did/Did Not Receive Leuprolide Following Bone Marrow Transplant (BMT)
Males that did not receive leuprolide
|
21.9 percentage of cells
Interval 0.2 to 32.5
|
—
|
—
|
—
|
—
|
|
Percentage of B Cells at One Year Post-transplant in Participants Who Did/Did Not Receive Leuprolide Following Bone Marrow Transplant (BMT)
Males that received leuprolide
|
22.1 percentage of cells
Interval 2.2 to 30.7
|
—
|
—
|
—
|
—
|
|
Percentage of B Cells at One Year Post-transplant in Participants Who Did/Did Not Receive Leuprolide Following Bone Marrow Transplant (BMT)
Females who all received leuprolide
|
14.3 percentage of cells
Interval 2.1 to 50.5
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 18F FLT scan done between days +5 to +12 and then time from that scan to engraftment measuredPopulation: The pre-specified cohort for this endpoint was 23 first BMT recipients. Only 20 of 23 were evaluable due to inability to obtain the early scan (1) or early relapse (2). As pre-specified in the protocol, all 20 patients were analyzed together as the intention was to look at the imaging modality itself and not any effect of leuprolide.
18F-FLT imaging was performed serially on patients post transplant to identify the level of uptake of 18F-FLT at a day +5 to +12 scan and the day at which neutrophils recover to \>500 (i.e., subclinical bone-marrow recovery within 5 days of Bone Marrow Transplantation (BMT infusion)). On each image for each patient, the region of interest was drawn within each thoracic medullary space (n=12), generating the SUV for each space. The mean of these was calculated for each scan. The analysis was the median of the means of the SUV of the thorax values of the day 5-12 scan (averaged the SUV of the thorax for each patient and then took the medians of these).
Outcome measures
| Measure |
Transplant Recipient
n=20 Participants
Patients receiving first allogeneic bone marrow transplant on this study.
|
Males Randomized to Receive Leuprolide for 1st Transplant
Males undergoing first transplant who were randomized to receive leuprolide.
|
Females That Received Leuprolide for 1st Transplant
Females undergoing first transplant who all received leuprolide.
|
Matched Related Donors for Transplant
Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic Bone Marrow Transplant on this study.
|
Recipients of 2nd Transplant
Patients receiving second allogeneic Bone Marrow Transplant on this study.
|
|---|---|---|---|---|---|
|
Time to Engraftment in First Transplant Recipients Only With Median Thoracic Spine Standardized Uptake Values (SUV) of 1.4 or Greater Than Those Patients With SUV's Less Than 1.4
Patients with SUV 1.4 or greater
|
5 Days
Interval 3.0 to 13.0
|
—
|
—
|
—
|
—
|
|
Time to Engraftment in First Transplant Recipients Only With Median Thoracic Spine Standardized Uptake Values (SUV) of 1.4 or Greater Than Those Patients With SUV's Less Than 1.4
Patients with SUV less than 1.4
|
15 Days
Interval 8.0 to 22.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 months after second BMTPopulation: Only the patients in the SG4 group who had a 2nd BMT had a primary endpoint of toxicity requiring leuprolide AE reporting.
Serious and non-serious adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). 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 |
Transplant Recipient
n=2 Participants
Patients receiving first allogeneic bone marrow transplant on this study.
|
Males Randomized to Receive Leuprolide for 1st Transplant
Males undergoing first transplant who were randomized to receive leuprolide.
|
Females That Received Leuprolide for 1st Transplant
Females undergoing first transplant who all received leuprolide.
|
Matched Related Donors for Transplant
Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic Bone Marrow Transplant on this study.
|
Recipients of 2nd Transplant
Patients receiving second allogeneic Bone Marrow Transplant on this study.
|
|---|---|---|---|---|---|
|
Number of Adverse Events Related to Study Drug Experienced by Participants After Second Bone Marrow Transplant (BMT)
|
0 Adverse Events
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 79 months and 11 days.Population: 40/45 transplant recipients and all 31 donors were evaluable for adverse events as five patients did not proceed to transplant after enrollment due to progression of disease in four cases and enrollment on a new protocol in one case.
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). 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 |
Transplant Recipient
n=10 Participants
Patients receiving first allogeneic bone marrow transplant on this study.
|
Males Randomized to Receive Leuprolide for 1st Transplant
n=8 Participants
Males undergoing first transplant who were randomized to receive leuprolide.
|
Females That Received Leuprolide for 1st Transplant
n=20 Participants
Females undergoing first transplant who all received leuprolide.
|
Matched Related Donors for Transplant
n=31 Participants
Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic Bone Marrow Transplant on this study.
|
Recipients of 2nd Transplant
n=2 Participants
Patients receiving second allogeneic Bone Marrow Transplant on this study.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
|
10 Participants
|
8 Participants
|
20 Participants
|
4 Participants
|
2 Participants
|
Adverse Events
Males That Did Not Receive Leuprolide for 1st Transplant
Serious events: 5 serious events
Other events: 10 other events
Deaths: 4 deaths
Males Randomized to Receive Leuprolide for 1st Transplant
Serious events: 6 serious events
Other events: 8 other events
Deaths: 3 deaths
Females That Received Leuprolide for 1st Transplant
Serious events: 15 serious events
Other events: 20 other events
Deaths: 8 deaths
Matched Related Donors for Transplant
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Recipients of 2nd Transplant
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Males That Did Not Receive Leuprolide for 1st Transplant
n=10 participants at risk
Males undergoing first transplant who did not receive leuprolide.
|
Males Randomized to Receive Leuprolide for 1st Transplant
n=8 participants at risk
Males undergoing first transplant who were randomized to receive leuprolide.
|
Females That Received Leuprolide for 1st Transplant
n=20 participants at risk
Females undergoing first transplant who all received leuprolide.
|
Matched Related Donors for Transplant
n=31 participants at risk
Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic bone marrow transplant on this study.
|
Recipients of 2nd Transplant
n=2 participants at risk
Patients receiving second allogeneic bone marrow transplant on this study.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Acidosis
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Eye disorders
Cataract
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Eye disorders
Corneal ulcer
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Cystitis noninfective
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
General disorders
Death NOS
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.0%
2/10 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
5/20 • Number of events 8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
6.5%
2/31 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, E.coli (blood, lungs)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Fever, neutropenia
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
5/20 • Number of events 8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Influenza H1N1
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Kaposi's sarcoma (HHV8)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, PCP Pneumonia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Parainfluenza III
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Presumed fungal
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Pseudomonas bacter
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, RSV
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Stenotrophom maltophilia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Stenotrophomonas bacteremia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, adeno viremia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, presumed bacterial infection
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Candida glabrata in blood
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Lung infection
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
2/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Meningitis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, acidosis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
General disorders
Multi-organ failure
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
General disorders
Pain
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, renal failure
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Renal hemorrhage
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
20.0%
4/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
100.0%
2/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Sepsis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
20.0%
4/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and Infestations - Other, Candida glabrata in blood
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
Other adverse events
| Measure |
Males That Did Not Receive Leuprolide for 1st Transplant
n=10 participants at risk
Males undergoing first transplant who did not receive leuprolide.
|
Males Randomized to Receive Leuprolide for 1st Transplant
n=8 participants at risk
Males undergoing first transplant who were randomized to receive leuprolide.
|
Females That Received Leuprolide for 1st Transplant
n=20 participants at risk
Females undergoing first transplant who all received leuprolide.
|
Matched Related Donors for Transplant
n=31 participants at risk
Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic bone marrow transplant on this study.
|
Recipients of 2nd Transplant
n=2 participants at risk
Patients receiving second allogeneic bone marrow transplant on this study.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Pain, bilateral shins/ankles R>L
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • Number of events 6 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
45.0%
9/20 • Number of events 13 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Lung infection
|
50.0%
5/10 • Number of events 7 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
37.5%
3/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
5/20 • Number of events 7 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Meningitis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
37.5%
3/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
20.0%
4/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
2/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
30.0%
6/20 • Number of events 8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
4/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
30.0%
6/20 • Number of events 10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Agitation
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
60.0%
6/10 • Number of events 24 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
4/8 • Number of events 8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
70.0%
14/20 • Number of events 45 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Alkaline phosphatase increased
|
30.0%
3/10 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 6 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
5/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Anemia
|
90.0%
9/10 • Number of events 28 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
62.5%
5/8 • Number of events 28 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
60.0%
12/20 • Number of events 39 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
9.7%
3/31 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
100.0%
2/2 • Number of events 4 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
10.0%
2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Ascites
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
5/10 • Number of events 14 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
37.5%
3/8 • Number of events 5 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
65.0%
13/20 • Number of events 36 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Blood bilirubin increased
|
30.0%
3/10 • Number of events 4 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
5/20 • Number of events 10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Eye disorders
Blurred vision
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
CPK increased
|
10.0%
1/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
2/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Eye disorders
Cataract
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Hepatobiliary disorders
Cholecystitis
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
15.0%
3/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Colitis
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Colonic ulcer
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Corneal infection
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Creatinine increased
|
10.0%
1/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
5/20 • Number of events 7 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Delirium
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Depression
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
10.0%
2/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
4/10 • Number of events 5 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
62.5%
5/8 • Number of events 6 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
10/20 • Number of events 12 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
100.0%
2/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Eye disorders
Dry eye
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
20.0%
4/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
General disorders
Edema limbs
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Ejection fraction decreased
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Endocrine disorders
Endocrine disorders - Other, Hypoganadism
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Enterocolitis
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Esophagitis
|
10.0%
1/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
2/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
35.0%
7/20 • Number of events 7 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
General disorders
Fever
|
40.0%
4/10 • Number of events 5 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
2/8 • Number of events 5 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
30.0%
6/20 • Number of events 7 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Fibrinogen decreased
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
10.0%
2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Melanotic Stool
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Hallucinations
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
10.0%
2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Hematuria
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, Hepatic steatosis
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, Ductal injury consistent w/GVHD, portal hypertension
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, acute liver injury
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, liver GVHD
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.0%
3/10 • Number of events 12 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
5/20 • Number of events 8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
15.0%
3/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
20.0%
2/10 • Number of events 4 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
40.0%
8/20 • Number of events 9 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
10.0%
1/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
2/10 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
40.0%
8/20 • Number of events 9 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
37.5%
3/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
20.0%
4/20 • Number of events 5 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
60.0%
6/10 • Number of events 17 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
37.5%
3/8 • Number of events 5 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
10/20 • Number of events 13 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
2/10 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
20.0%
4/20 • Number of events 5 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
80.0%
8/10 • Number of events 15 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
4/8 • Number of events 6 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
60.0%
12/20 • Number of events 21 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
100.0%
2/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
General disorders
Hypothermia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Ileal hemorrhage
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, 6/24 Aeromonas infection of stool
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Adenoviremia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Ascaris lubricoides in stool
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, BK cystitis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, BK virus
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Blood cultures were positive for GPC/bacteremia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Blood cx: CMV+ ; CMV reactivation
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, C. diff
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, C. diff PCR+ 4/21
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, C. diff PCR+ 6/5
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, CMV
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, CMV (blood)
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
10.0%
2/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, CMV (blood, BAL, GI)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, CMV colitis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, CMV reactivation
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
30.0%
6/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, CMV reactivation (1600 copies)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, CMV reactivation (blood)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, CMV reactivation +6350 copies
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, CMV reactivation and presumed CMV infection of GI.
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, CMV viremia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, CMV viremia, CMV gastritis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, CMV-esophagitis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Coagulase-negative Staph, Rhinovirus/enterovirus
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Coronavirus
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Coronavirus 229E (nasal wash, upper respiratory)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, E.coli (UTI)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, EBV+PCR 3600 copies
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, ESBL Klebsiella urinary tract infection
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, ESBL bacteremia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Enteroaggregative E.coli (stool)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Enterococcus in blood
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Enteropathogenic E.coli (stool)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, GI tract
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Geotricum Capitatum
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Giardia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, HHV6 (CSF)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, HSV oral ulcers
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Herpes zoster
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Human metapneumovirus
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
10.0%
2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Hypotension
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Influenza B
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Klebsiela pneumonia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Klebsiella, serratia, stenotrophomonas
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Lymphadenitis (inguinal lymph node)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Mumps
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, NP wash - rhinovirus
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Nocardia pulmonary infection
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, PICC, S.mitis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Pleseimonas shigelloides (stool)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Presumed fungal - BAL (pulmonary)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Pseudomonas aeruginosa (skin lesion)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, RSV
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Rhino/enterovirus
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Rhinovirus/enterovirus (NP wash)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Rotavirus
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Rothia (Stomatococcus) mucilaginosus;
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, STAPH EPI from CSF
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Shiga-like E.coli (SREC)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Staph epi, Enterococcus faecalis in blood
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Staph. Capitis product infection
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, THRUSH
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, VRE bacteremia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, VZV
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, VZV zoster
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Vancomycin-resistant Enterococcus
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Varicella zoster (back, abdomen)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Varicella zoster- L thoracic area
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, adenovirus
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, adenovirus viremia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, bacterial vaginosis and C.albicans
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, bronchscopy - aspergillus
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, clostridium tertium
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, coronaviral URI (intermittent)
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, fungal (yeast in blood)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, lung microbiology
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, norovirus
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, oral candidiasis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, pneumonia-unknown organism
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, presumed BK virus
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, presumed bacterial
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, presumed fungal pneumonia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, presumed pneumonia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, presumed pneumonia, yeast infection
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, presumed viral
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, rhinovirus/enterovirus
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, staph aureus (sinusitis)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Clostridium difficile - stool
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, HHV-6 (alveolar inf.)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Human rhinovirus/enterovirus
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, Staph epidermitis in blood (port inf.)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, intermittent bacteremia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Eye disorders
Keratitis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Lipase increased
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Neutrophil count decreased
|
100.0%
10/10 • Number of events 49 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
87.5%
7/8 • Number of events 32 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
75.0%
15/20 • Number of events 83 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Oral pain
|
30.0%
3/10 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
20.0%
4/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Ear and labyrinth disorders
Otitis externa
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
General disorders
Pain
|
40.0%
4/10 • Number of events 5 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
5/20 • Number of events 5 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
10.0%
2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
3.2%
1/31 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Platelet count decreased
|
100.0%
10/10 • Number of events 43 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
87.5%
7/8 • Number of events 53 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
70.0%
14/20 • Number of events 49 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
100.0%
2/2 • Number of events 6 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Psychiatric disorders
Psychiatric disorders - Other, acute mental status changes
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
30.0%
3/10 • Number of events 6 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
30.0%
3/10 • Number of events 5 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
37.5%
3/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
5/20 • Number of events 5 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Rectal mucositis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, renal insufficiency
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, Dyspareunia, Vaginal dryness
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, Vaginal bleeding
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, vaginal scarring and stenosis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Eye disorders
Retinal tear
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
10.0%
2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Serum amylase increased
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
2/10 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
20.0%
4/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Porokeratosis - buttocks
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, cGVHD, scleroderma, rash
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, pimple-llike lesions neck, fase, chest
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, rash
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
20.0%
2/10 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Injury, poisoning and procedural complications
Stomal ulcer
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
10.0%
2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
10.0%
1/10 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
15.0%
3/20 • Number of events 5 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Vascular disorders
Vascular disorders - Other, Anasarca B/L
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Vascular disorders
Vascular disorders - Other, TAM-transfusion associated microangiopathy
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
5/10 • Number of events 5 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Weight gain
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
15.0%
3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
Weight loss
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
10.0%
2/20 • Number of events 5 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Investigations
White blood cell decreased
|
100.0%
10/10 • Number of events 33 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
50.0%
4/8 • Number of events 46 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
80.0%
16/20 • Number of events 56 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
100.0%
2/2 • Number of events 6 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, membranous nephropathy
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, pneumonia, presumed fungal
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, BK virus (urine infection)
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/20 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
|
Infections and infestations
Infections and infestations - Other, E. coli
|
0.00%
0/10 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
5.0%
1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/31 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 79 months and 11 days.
40/45 participants were evaluable for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place