Trial Outcomes & Findings for GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies (NCT NCT03214666)
NCT ID: NCT03214666
Last Updated: 2022-11-10
Results Overview
The study was terminated prior to reaching the maximal tolerated dose. This outcome measure presents information regarding the number of participants receiving each dose of GTB-3550.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Day 1 (start of GTB-3550 therapy)
Results posted on
2022-11-10
Participant Flow
Participant milestones
| Measure |
GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day
Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day
Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day
Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day
Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day
Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day
Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Dose Level 1: 5 ug/kg/Day
STARTED
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 1: Dose Level 1: 5 ug/kg/Day
COMPLETED
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 1: Dose Level 1: 5 ug/kg/Day
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 2: Dose Level 2: 10ug/kg/Day
STARTED
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Cohort 2: Dose Level 2: 10ug/kg/Day
COMPLETED
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Cohort 2: Dose Level 2: 10ug/kg/Day
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 3: Dose Level 3: 25 ug/kg/Day
STARTED
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Cohort 3: Dose Level 3: 25 ug/kg/Day
COMPLETED
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Cohort 3: Dose Level 3: 25 ug/kg/Day
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 4: Dose Level 4: 50 ug/kg/Day
STARTED
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Cohort 4: Dose Level 4: 50 ug/kg/Day
COMPLETED
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Cohort 4: Dose Level 4: 50 ug/kg/Day
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Cohort 5: Dose Level 5: 100 ug/kg/Day
STARTED
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Cohort 5: Dose Level 5: 100 ug/kg/Day
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Cohort 5: Dose Level 5: 100 ug/kg/Day
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Cohort 6: Dose Level 6: 150 ug/kg/Day
STARTED
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Cohort 6: Dose Level 6: 150 ug/kg/Day
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Cohort 6: Dose Level 6: 150 ug/kg/Day
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day
Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day
Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day
Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day
Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day
Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day
Patients receive a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks. Each block consisted of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE® followed by a 72 hour break after Block #1 and #2. All treatment was given as an inpatient. The assigned dose was calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose was not recalculated for subsequent treatment blocks.
|
|---|---|---|---|---|---|---|
|
Cohort 5: Dose Level 5: 100 ug/kg/Day
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies
Baseline characteristics by cohort
| Measure |
GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
8 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=7 Participants
|
2 participants
n=31 Participants
|
2 participants
n=30 Participants
|
2 participants
n=3 Participants
|
|
Baseline Disease
Relapsed/Refractory Acute Myeloid Leukemia (AML) - Secondary AML
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
|
Baseline Disease
Relapsed/Refractory AML - de novo AML
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
|
Baseline Disease
Relapsed/Refractory AML - Treatment-related
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Baseline Disease
Myelodysplastic Syndrome (MDS)
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
|
Number of Prior Lines of Cancer Therapy
2
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
|
Number of Prior Lines of Cancer Therapy
3
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
|
Number of Prior Lines of Cancer Therapy
4
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Number of Prior Lines of Cancer Therapy
5
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Number of Prior Lines of Cancer Therapy
6
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Number of Prior Lines of Cancer Therapy
7
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
|
Number of Prior Lines of Cancer Therapy
9
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Day 1 (start of GTB-3550 therapy)The study was terminated prior to reaching the maximal tolerated dose. This outcome measure presents information regarding the number of participants receiving each dose of GTB-3550.
Outcome measures
| Measure |
GTB-3550 TriKE® (Phase I: Dose Finding Component)
n=12 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose as 3 weekly treatment blocks. Patients were assigned 1 of 6 dose levels from 5-150 μg/kg/day.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.
|
|---|---|---|---|---|---|---|
|
GTB-3550 Dosing Summary
5 ug/kg/day Dose
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
GTB-3550 Dosing Summary
10 ug/kg/day Dose
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
GTB-3550 Dosing Summary
25 ug/kg/day Dose
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
GTB-3550 Dosing Summary
50 ug/kg/day Dose
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
GTB-3550 Dosing Summary
100 ug/kg/day Dose
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
GTB-3550 Dosing Summary
150 ug/kg/day Dose
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 28 relative to the start of GTB-3550 therapyThis outcome measure summarizes the number of GTB-3550 treatment blocks participants received during the first cycle of treatment.
Outcome measures
| Measure |
GTB-3550 TriKE® (Phase I: Dose Finding Component)
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose as 3 weekly treatment blocks. Patients were assigned 1 of 6 dose levels from 5-150 μg/kg/day.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.
|
|---|---|---|---|---|---|---|
|
GTB-3550 Extent of Treatment (Summary)
Number of Participants Completing Blocks 1-3
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
GTB-3550 Extent of Treatment (Summary)
Number of Participants Completing Only Blocks 1 and 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28 relative to the start of GTB-3550 therapyThe number of unexpected events in relation to GTB-3550 TriKE®. TEAEs were measured up to Day 28 relative to GTB-3550 therapy.
Outcome measures
| Measure |
GTB-3550 TriKE® (Phase I: Dose Finding Component)
n=62 TEAEs Regardless of Relationship
Patients received a single course of GTB-3550 TriKE® at their assigned dose as 3 weekly treatment blocks. Patients were assigned 1 of 6 dose levels from 5-150 μg/kg/day.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day
n=48 TEAEs Regardless of Relationship
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day
n=70 TEAEs Regardless of Relationship
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day
n=28 TEAEs Regardless of Relationship
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day
n=62 TEAEs Regardless of Relationship
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day
n=113 TEAEs Regardless of Relationship
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.
|
|---|---|---|---|---|---|---|
|
Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
Unexpected and Related TEAEs
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
3 Events
|
|
Number of GTB-3550 TriKE® Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
Unexpected and Related Serious Adverse Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: 6 MonthsNumber of patients surviving at 6 months post-treatment on this study.
Outcome measures
| Measure |
GTB-3550 TriKE® (Phase I: Dose Finding Component)
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose as 3 weekly treatment blocks. Patients were assigned 1 of 6 dose levels from 5-150 μg/kg/day.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: After Day 28 Relative to GTB-3550 TherapyBlast count was measured at the time of standard of care disease assessment after GTB-3550 therapy. Blast percent was assessed by morphology and/or flow cytometry.
Outcome measures
| Measure |
GTB-3550 TriKE® (Phase I: Dose Finding Component)
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose as 3 weekly treatment blocks. Patients were assigned 1 of 6 dose levels from 5-150 μg/kg/day.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.
|
|---|---|---|---|---|---|---|
|
Number of Participants Experiencing a Reduction in Blast Count Post-GTB-3550 Therapy
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
POST_HOC outcome
Timeframe: 2-4 weeks after completion of the 1st cycle of therapyParticipants with lack of disease progression or evidence of a clinical improvement had the opportunity to receive an optional 2nd cycle of therapy ('retreatment').
Outcome measures
| Measure |
GTB-3550 TriKE® (Phase I: Dose Finding Component)
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose as 3 weekly treatment blocks. Patients were assigned 1 of 6 dose levels from 5-150 μg/kg/day.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day
n=2 Participants
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.
|
|---|---|---|---|---|---|---|
|
Number of Participants Proceeding to an Optional 2nd Cycle of GTB-3550 Therapy
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day
n=2 participants at risk
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day
n=2 participants at risk
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day
n=2 participants at risk
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day
n=2 participants at risk
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day
n=2 participants at risk
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day
n=2 participants at risk
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
Other adverse events
| Measure |
GTB-3550 TriKE® (Phase I: Dose Finding Component): 5 ug/kg/Day
n=2 participants at risk
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 5 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 10 ug/kg/Day
n=2 participants at risk
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 10 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 25 ug/kg/Day
n=2 participants at risk
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 25 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 50 ug/kg/Day
n=2 participants at risk
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 50 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 100 ug/kg/Day
n=2 participants at risk
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 100 ug/kg/day as 3 weekly treatment blocks.
|
GTB-3550 TriKE® (Phase I: Dose Finding Component): 150 ug/kg/Day
n=2 participants at risk
Patients received a single course of GTB-3550 TriKE® at their assigned dose of 150 ug/kg/day as 3 weekly treatment blocks.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 12 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Blood and lymphatic system disorders
LDH Increase
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Blood and lymphatic system disorders
C-reactive protein increase
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Cardiac disorders
Sinus tachycardia
|
50.0%
1/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 4 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 6 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Gastrointestinal disorders
Flatulence
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Gastrointestinal disorders
Gingival bleeding/blood blister
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
General disorders
Chills
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 6 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
General disorders
Edema limbs
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 5 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 4 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
General disorders
Fever
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 4 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 14 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
General disorders
IL-6 Increase
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
General disorders
Chloride increased
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
General disorders
Pain
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Immune system disorders
Cytokine release syndrome
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 4 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
Blood bilirubin increased
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
Creatinine increased
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 4 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 8 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 5 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
INR increased
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
IL-6 increase
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
LDH elevated - intermittent
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
Ferritin elevation
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
CRP elevation
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
Fibrinogen elevation
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
Chloride increase - intermittent
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
Lymphocyte count decreased
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 7 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 6 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 4 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Number of events 5 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
Platelet count decreased
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 7 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Investigations
White blood cell decreased
|
50.0%
1/2 • Number of events 5 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 4 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 4 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
2/2 • Number of events 4 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 13 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 4 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 4 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms, intermittent
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Psychiatric disorders
Anxiety
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Psychiatric disorders
Restlesness
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 4 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Respiratory, thoracic and mediastinal disorders
On oxygen with no documented hypoxia, intermittent
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Skin and subcutaneous tissue disorders
Rash - L leg
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 3 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
|
Vascular disorders
Hypotension
|
50.0%
1/2 • Number of events 4 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
0.00%
0/2 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
100.0%
2/2 • Number of events 7 • Adverse event data was collected beginning with the first dose of GTB-3550 (Day 1) through Day 29 after the start of GTB-3550 therapy. All-cause mortality was monitored for up to 6 months after the start of GTB-3550 therapy.
Adverse events were assessed at the following study timepoint: prior to the infusion start of each 24 hour infusion (i.e. Days 1-4, 8-11 and 15-18), at the end of the final infusion of each block (i.e. Days 5, 12, and 19), Day 22 and Day 29.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60