Trial Outcomes & Findings for Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation (NCT NCT02356159)
NCT ID: NCT02356159
Last Updated: 2025-09-30
Results Overview
The estimated percent of participants who experienced severe chronic graft versus host disease (GVHD) was assessed by the 1994 Consensus Conference Working Criteria. Severe GVHD is defined using the Global Staging per 2014 National Institutes of Health (NIH) Consensus Criteria for chronic GVHD.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
34 participants
Primary outcome timeframe
60 months
Results posted on
2025-09-30
Participant Flow
Participant milestones
| Measure |
Phase I Palifermin Dose Level 1: 180 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 2: 360 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 3: 540 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 4: 720 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase 2 Palifermin 720 mcg/kg Intravenous (IV) Dose
Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Participants Enrolled But Not Treated on the Research Phase (Palifermin + Transplant).
Participants were enrolled but not treated on the Research Phase (Palifermin + transplant).
|
|---|---|---|---|---|---|---|
|
Total Enrolled
STARTED
|
6
|
3
|
3
|
3
|
16
|
3
|
|
Total Enrolled
Eligible for Induction Phase
|
5
|
2
|
3
|
2
|
2
|
2
|
|
Total Enrolled
Eligible for Research Phase
|
6
|
3
|
3
|
3
|
16
|
1
|
|
Total Enrolled
COMPLETED
|
6
|
3
|
3
|
3
|
16
|
3
|
|
Total Enrolled
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Induction Phase (Ph)
STARTED
|
5
|
2
|
3
|
2
|
2
|
2
|
|
Induction Phase (Ph)
COMPLETED
|
5
|
2
|
3
|
2
|
2
|
2
|
|
Induction Phase (Ph)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 180mcg/kg
STARTED
|
6
|
0
|
0
|
0
|
0
|
1
|
|
Research Ph, Ph I Dose Level 180mcg/kg
Palifermin
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 180mcg/kg
Conditioning Chemotherapy
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 180mcg/kg
Transplant
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 180mcg/kg
Immunosuppression Graft Versus Host Disease (GVHD) Prophylaxis
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 180mcg/kg
COMPLETED
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 180mcg/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Research Ph, Ph I Dose Level 2 360mcg/kg
STARTED
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 2 360mcg/kg
Palifermin
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 2 360mcg/kg
Conditioning Chemotherapy
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 2 360mcg/kg
Transplant
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 2 360mcg/kg
Immunosuppression Graft Versus Host Disease (GVHD) Prophylaxis
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 2 360mcg/kg
COMPLETED
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 2 360mcg/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 3 540mcg/kg
STARTED
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 3 540mcg/kg
Palifermin
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 3 540mcg/kg
Conditioning Chemotherapy
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 3 540mcg/kg
Transplant
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 3 540mcg/kg
Immunosuppression Graft Versus Host Disease (GVHD) Prophylaxis
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 3 540mcg/kg
COMPLETED
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 3 540mcg/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Research Ph, Ph I Dose Level 4 720mcg/kg
STARTED
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Research Ph, Ph I Dose Level 4 720mcg/kg
Palifermin
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Research Ph, Ph I Dose Level 4 720mcg/kg
Conditioning Chemotherapy
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Research Ph, Ph I Dose Level 4 720mcg/kg
Transplant
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Research Ph, Ph I Dose Level 4 720mcg/kg
Immunosuppression Graft Versus Host Disease (GVHD) Prophylaxis
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Research Ph, Ph I Dose Level 4 720mcg/kg
COMPLETED
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Research Ph, Ph I Dose Level 4 720mcg/kg
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase II - Maximum Tolerated Dose
STARTED
|
0
|
0
|
0
|
0
|
16
|
0
|
|
Phase II - Maximum Tolerated Dose
Palifermin
|
0
|
0
|
0
|
0
|
16
|
0
|
|
Phase II - Maximum Tolerated Dose
Conditioning Chemotherapy
|
0
|
0
|
0
|
0
|
16
|
0
|
|
Phase II - Maximum Tolerated Dose
Transplant
|
0
|
0
|
0
|
0
|
16
|
0
|
|
Phase II - Maximum Tolerated Dose
Immunosuppression Graft Versus Host Disease (GVHD) Prophylaxis
|
0
|
0
|
0
|
0
|
16
|
0
|
|
Phase II - Maximum Tolerated Dose
COMPLETED
|
0
|
0
|
0
|
0
|
16
|
0
|
|
Phase II - Maximum Tolerated Dose
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I Palifermin Dose Level 1: 180 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 2: 360 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 3: 540 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 4: 720 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase 2 Palifermin 720 mcg/kg Intravenous (IV) Dose
Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Participants Enrolled But Not Treated on the Research Phase (Palifermin + Transplant).
Participants were enrolled but not treated on the Research Phase (Palifermin + transplant).
|
|---|---|---|---|---|---|---|
|
Research Ph, Ph I Dose Level 180mcg/kg
No longer eligible for research phase
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
Baseline characteristics by cohort
| Measure |
Phase I Palifermin Dose Level 1: 180 mcg/kg Intravenous (IV) on Day-7
n=6 Participants
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 2: 360 mcg/kg Intravenous (IV) on Day-7
n=3 Participants
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 3: 540 mcg/kg Intravenous (IV) on Day-7
n=3 Participants
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 4: 720 mcg/kg Intravenous (IV) on Day-7
n=3 Participants
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase 2 Palifermin: 720 mcg/kg Intravenous (IV) Dose
n=16 Participants
Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Participants Enrolled But Not Treated on Research Phase (Palifermin + Transplant)
n=3 Participants
Participants were enrolled but not treated on Research Phase (Palifermin + Transplant).
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
33 Participants
n=8 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
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 10.01 • n=5 Participants
|
55.67 years
STANDARD_DEVIATION 8.62 • n=7 Participants
|
31 years
STANDARD_DEVIATION 10.15 • n=5 Participants
|
46.33 years
STANDARD_DEVIATION 11.06 • n=4 Participants
|
35.19 years
STANDARD_DEVIATION 12.5 • n=21 Participants
|
61 years
STANDARD_DEVIATION 7 • n=8 Participants
|
42.41 years
STANDARD_DEVIATION 14.23 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
18 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
16 participants
n=21 Participants
|
3 participants
n=8 Participants
|
34 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 60 monthsPopulation: The total number of participants analyzed for the primary outcome measure is 19 (16 enrolled on the phase 2 Arm and data/outcomes on the 3 participants from phase 1 treated at dose level 4).
The estimated percent of participants who experienced severe chronic graft versus host disease (GVHD) was assessed by the 1994 Consensus Conference Working Criteria. Severe GVHD is defined using the Global Staging per 2014 National Institutes of Health (NIH) Consensus Criteria for chronic GVHD.
Outcome measures
| Measure |
2/Phase II Arm - Palifermin at the Recommended Phase 2 Dose
n=19 Participants
Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 2: 360 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 3: 540 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 4: 720 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase 2 Palifermin: 720 mcg/kg Intravenous (IV) Dose
Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Participants Enrolled But Not Treated on Research Phase (Palifermin + Transplant)
Participants were enrolled but not treated on Research Phase (Palifermin + Transplant).
|
|---|---|---|---|---|---|---|
|
Phase II: Estimated Percent of Participants Who Experienced Severe Chronic Graft Versus Host Disease (GVHD)
|
6.0 Estimated percent of participants
Interval 0.3 to 24.7
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Approximately 30-day post-transplantPopulation: All participants = (total # for phase 1).
MTD is defined as the dose level at which no more than 1 (of ≤ 6) participants who experience dose-limiting toxicity (DLT), and the dose below that at which at least 2 (of ≤ 6) participants have a DLT as a result of the drug. A DLT is non-relapse mortality before day 30 post transplantation regardless of attribution to palifermin. and non-hematologic grade 4 (life-threatening) adverse events within 14 days after treatment with palifermin possibly related to drug.
Outcome measures
| Measure |
2/Phase II Arm - Palifermin at the Recommended Phase 2 Dose
n=15 Participants
Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 2: 360 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 3: 540 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 4: 720 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase 2 Palifermin: 720 mcg/kg Intravenous (IV) Dose
Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Participants Enrolled But Not Treated on Research Phase (Palifermin + Transplant)
Participants were enrolled but not treated on Research Phase (Palifermin + Transplant).
|
|---|---|---|---|---|---|---|
|
Phase I: Maximum Tolerated Dose (MTD) of Palifermin
|
720 mcg/kg
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: ≤day 30 post-transplantPopulation: 15/16 participants were analyzed because 1 participant was a screen failure post induction for research phase.
A DLT is non-relapse mortality before day 30 post transplantation regardless of attribution to palifermin. Persons who expire from malignancy related causes are not considered DLTs; and non-hematologic Common Terminology Criteria for Adverse Events (CTCAE) ≥ grade 4 adverse events (AEs), occurring within 14 days after administration of palifermin that are determined by the investigator to be at least possibly related to the study drug. An isolated laboratory value is not considered an AE unless it meets the guidelines. Note: Participants will not be removed from study therapy due to palifermin toxicity as only 1 dose is administered. DLT criteria are established only to determine dose levels for subsequent participants.
Outcome measures
| Measure |
2/Phase II Arm - Palifermin at the Recommended Phase 2 Dose
n=15 Participants
Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 2: 360 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 3: 540 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 4: 720 mcg/kg Intravenous (IV) on Day-7
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase 2 Palifermin: 720 mcg/kg Intravenous (IV) Dose
Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Participants Enrolled But Not Treated on Research Phase (Palifermin + Transplant)
Participants were enrolled but not treated on Research Phase (Palifermin + Transplant).
|
|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With a Dose-limiting Toxicity (DLT)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years.Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for 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 |
2/Phase II Arm - Palifermin at the Recommended Phase 2 Dose
n=6 Participants
Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 2: 360 mcg/kg Intravenous (IV) on Day-7
n=3 Participants
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 3: 540 mcg/kg Intravenous (IV) on Day-7
n=3 Participants
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 4: 720 mcg/kg Intravenous (IV) on Day-7
n=3 Participants
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase 2 Palifermin: 720 mcg/kg Intravenous (IV) Dose
n=16 Participants
Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Participants Enrolled But Not Treated on Research Phase (Palifermin + Transplant)
n=3 Participants
Participants were enrolled but not treated on Research Phase (Palifermin + Transplant).
|
|---|---|---|---|---|---|---|
|
Phase I and/or Phase 2: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
|
6 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
16 Participants
|
0 Participants
|
Adverse Events
Phase I Palifermin Dose Level 1: 180 mcg/kg Intravenous (IV) on Day-7
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase I Palifermin Dose Level 2: 360 mcg/kg Intravenous (IV) on Day-7
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase I Palifermin Dose Level 3: 540 mcg/kg Intravenous (IV) on Day-7
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase I Palifermin Dose Level 4: 720 mcg/kg Intravenous (IV) on Day-7
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 2 Palifermin: 720 mcg/kg Intravenous (IV) Dose
Serious events: 5 serious events
Other events: 16 other events
Deaths: 6 deaths
Participants Enrolled But Not Treated on the Research Phase (Palifermin + Transplant)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I Palifermin Dose Level 1: 180 mcg/kg Intravenous (IV) on Day-7
n=6 participants at risk
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 2: 360 mcg/kg Intravenous (IV) on Day-7
n=3 participants at risk
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 3: 540 mcg/kg Intravenous (IV) on Day-7
n=3 participants at risk
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 4: 720 mcg/kg Intravenous (IV) on Day-7
n=3 participants at risk
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase 2 Palifermin: 720 mcg/kg Intravenous (IV) Dose
n=16 participants at risk
Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Participants Enrolled But Not Treated on the Research Phase (Palifermin + Transplant)
n=3 participants at risk
Participants were enrolled but not treated on Research Phase (Palifermin + Transplant).
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Corneal infection
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Eye disorders
Corneal ulcer
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
General disorders
Death NOS
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
25.0%
4/16 • Number of events 4 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, CMV reactivation
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, CMV infection
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, CMV Reactivation
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, CMV Viremia
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, Specify
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Investigations
Lipase increased
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Rhinitis infective
|
16.7%
1/6 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Sepsis
|
33.3%
2/6 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
12.5%
2/16 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Soft tissue infection
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
Other adverse events
| Measure |
Phase I Palifermin Dose Level 1: 180 mcg/kg Intravenous (IV) on Day-7
n=6 participants at risk
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 2: 360 mcg/kg Intravenous (IV) on Day-7
n=3 participants at risk
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 3: 540 mcg/kg Intravenous (IV) on Day-7
n=3 participants at risk
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase I Palifermin Dose Level 4: 720 mcg/kg Intravenous (IV) on Day-7
n=3 participants at risk
Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Phase 2 Palifermin: 720 mcg/kg Intravenous (IV) Dose
n=16 participants at risk
Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
|
Participants Enrolled But Not Treated on the Research Phase (Palifermin + Transplant)
n=3 participants at risk
Participants were enrolled but not treated on Research Phase (Palifermin + Transplant).
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Number of events 4 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
25.0%
4/16 • Number of events 4 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Psychiatric disorders
Agitation
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Nervous system disorders
Akathisia
|
16.7%
1/6 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
12.5%
2/16 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
12.5%
2/16 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Number of events 3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
66.7%
2/3 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Bladder infection
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Bloating
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
12.5%
2/16 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
66.7%
2/3 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Investigations
CPK increased
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
12.5%
2/16 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Investigations
Creatinine increased
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
General disorders
Death NOS (due to disease progression)
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
31.2%
5/16 • Number of events 6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
18.8%
3/16 • Number of events 3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
General disorders
Edema face
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
100.0%
3/3 • Number of events 3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
General disorders
Edema limbs
|
33.3%
2/6 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
18.8%
3/16 • Number of events 3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
18.8%
3/16 • Number of events 3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
2/6 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
66.7%
2/3 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
25.0%
4/16 • Number of events 4 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Tongue thickness
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Tongue thickness/discomfort
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
66.7%
2/3 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
43.8%
7/16 • Number of events 16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Cardiac disorders
Heart failure
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • Number of events 3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
12.5%
2/16 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
31.2%
5/16 • Number of events 7 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
66.7%
2/3 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
25.0%
4/16 • Number of events 5 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 5 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
66.7%
2/3 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
43.8%
7/16 • Number of events 10 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
66.7%
2/3 • Number of events 3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
37.5%
6/16 • Number of events 6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
66.7%
2/3 • Number of events 4 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
50.0%
8/16 • Number of events 19 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, +Coronavirus
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, +EBV>+2.70Log 10(intermittent)
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, Acinetobacter radioresistens
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, Bacteremia; E.coli
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, Bacteremia; Mycobacterium chelonae
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, CMV
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
12.5%
2/16 • Number of events 3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, CMV + biopsy
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, CMV Reactivation
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, CMV reactivation
|
33.3%
2/6 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
66.7%
2/3 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
12.5%
2/16 • Number of events 3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, COVID-19
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, EBV
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
12.5%
2/16 • Number of events 4 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, EBV Positive
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, EBV Reactivation
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, EBV reactivation
|
33.3%
2/6 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, Influenza B infection
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, Rhodotorula mucilaginosa (Yeast)
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Infections and infestations - Other, Stenotrophomonas Maltophilia+
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
General disorders
Infusion related reaction
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
12.5%
2/16 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Investigations
Lipase increased
|
33.3%
2/6 • Number of events 5 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
66.7%
2/3 • Number of events 4 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
18.8%
3/16 • Number of events 6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
General disorders
Malaise
|
16.7%
1/6 • Number of events 10 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, Low Vitamin D level
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 5 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
100.0%
3/3 • Number of events 4 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
62.5%
10/16 • Number of events 11 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Nervous system disorders
Nervous system disorders - Other, Presence of Chvostek sign (due to hypocalcemia)
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
12.5%
2/16 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
General disorders
Pain
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
18.8%
3/16 • Number of events 4 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
12.5%
2/16 • Number of events 3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Nervous system disorders
Paresthesia
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
66.7%
2/3 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
31.2%
5/16 • Number of events 5 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
100.0%
3/3 • Number of events 3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
100.0%
3/3 • Number of events 4 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
68.8%
11/16 • Number of events 12 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
12.5%
2/16 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Specify
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Investigations
Serum amylase increased
|
50.0%
3/6 • Number of events 5 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
66.7%
2/3 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
43.8%
7/16 • Number of events 20 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Specify
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, toxic erythema
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
18.8%
3/16 • Number of events 3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Injury, poisoning and procedural complications
Stomal ulcer
|
0.00%
0/6 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
6.2%
1/16 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Infections and infestations
Upper respiratory infection
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 5 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
43.8%
7/16 • Number of events 9 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
2/6 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Renal and urinary disorders
Urinary tract pain
|
16.7%
1/6 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/16 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 2 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
33.3%
1/3 • Number of events 1 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
31.2%
5/16 • Number of events 7 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
0.00%
0/3 • All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place