Trial Outcomes & Findings for Mogamulizumab and Pembrolizumab in Treating Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma (NCT NCT03309878)
NCT ID: NCT03309878
Last Updated: 2023-09-21
Results Overview
Will be determined by dose limiting toxicity (DLT). A standard 3+3 design will be used to find the MTD or RP2D for the combination of pembrolizumab and mogamulizumab.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Up to 6 weeks
Results posted on
2023-09-21
Participant Flow
Participant milestones
| Measure |
Phase I Dose Level 1
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 1 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1.5 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase I Dose Level -1
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 0.5 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm A
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab at dose identified in Phase I given by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab at dose identified in Phase I given by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm B
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
2
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I Dose Level 1
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 1 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1.5 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase I Dose Level -1
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 0.5 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm A
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab at dose identified in Phase I given by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab at dose identified in Phase I given by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm B
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Did not maintain eligibility
|
2
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Mogamulizumab and Pembrolizumab in Treating Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Phase I Dose Level 1
n=4 Participants
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 1 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1.5 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase I Dose Level -1
n=4 Participants
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 0.5 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm A
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab at dose identified in Phase I given by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab at dose identified in Phase I given by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm B
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71.5 years
n=5 Participants
|
55.5 years
n=7 Participants
|
—
|
—
|
64.5 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
—
|
—
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
—
|
—
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
—
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
—
|
—
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
—
|
—
|
8 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeksWill be determined by dose limiting toxicity (DLT). A standard 3+3 design will be used to find the MTD or RP2D for the combination of pembrolizumab and mogamulizumab.
Outcome measures
| Measure |
Phase I Dose Level 1
n=2 Participants
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 1 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1.5 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase I Dose Level -1
n=1 Participants
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 0.5 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm A
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab at dose identified in Phase I given by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab at dose identified in Phase I given by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm B
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D) of Mogamulizumab in Combination With Pembrolizumab (Phase I)
Dose limiting toxicity occurred
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D) of Mogamulizumab in Combination With Pembrolizumab (Phase I)
Dose limiting toxicity did not occur
|
2 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 25 monthsNumber of incidences of grade 3-5 adverse events at least possibly related to the study intervention will be reported. Adverse events will be graded according to Common Terminology Criteria for Adverse Events version 4.03 (Version 5.0 beginning April 1, 2018).
Outcome measures
| Measure |
Phase I Dose Level 1
n=2 Participants
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 1 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1.5 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase I Dose Level -1
n=1 Participants
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 0.5 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm A
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab at dose identified in Phase I given by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab at dose identified in Phase I given by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm B
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Incidence of Adverse Events (Phase I)
Experienced Grade 4 Adverse Events
|
5 Related Incidences
|
0 Related Incidences
|
—
|
—
|
|
Incidence of Adverse Events (Phase I)
Experienced Grade 5 Adverse Events
|
0 Related Incidences
|
1 Related Incidences
|
—
|
—
|
|
Incidence of Adverse Events (Phase I)
Experienced Grade 3 Adverse Events
|
4 Related Incidences
|
0 Related Incidences
|
—
|
—
|
PRIMARY outcome
Timeframe: From course 1 day 1 to the first date of recurrence, progression, or death due to any cause, whichever comes first, assessed up to 12 monthsPopulation: Study closed before conducting Phase II.
The Kaplan Meier method will be used to estimate the median PFS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 25 monthsPopulation: Study closed before conducting Phase II.
Will be calculated along with exact 95% confidence intervals.
Outcome measures
| Measure |
Phase I Dose Level 1
n=2 Participants
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 1 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1.5 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase I Dose Level -1
n=1 Participants
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 0.5 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm A
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab at dose identified in Phase I given by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab at dose identified in Phase I given by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm B
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Overall Response Rate
Experienced Complete Response
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Overall Response Rate
Experienced Partial Response
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Overall Response Rate
Experienced Stable Disease
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Overall Response Rate
Experienced Disease Progression
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Overall Response Rate
Not evaluated
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 25 monthsPopulation: Study closed before conducting Phase II.
Will be calculated along with exact 95% confidence intervals.
Outcome measures
| Measure |
Phase I Dose Level 1
n=2 Participants
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 1 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1.5 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase I Dose Level -1
n=1 Participants
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 0.5 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm A
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab at dose identified in Phase I given by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab at dose identified in Phase I given by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm B
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Complete Response Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 25 monthsPopulation: Study closed before conducting Phase II.
Will be calculated along with exact 95% confidence intervals.
Outcome measures
| Measure |
Phase I Dose Level 1
n=2 Participants
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 1 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1.5 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase I Dose Level -1
n=1 Participants
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 0.5 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm A
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab at dose identified in Phase I given by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab at dose identified in Phase I given by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase II Arm B
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|---|---|
|
Partial Response Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 25 monthsPopulation: Participants in Phase I (Dose Levels 1 and -1) did not experience complete response or partial response. Study closed before conducting Phase II.
Will be summarized by Kaplan-Meier method in patients who achieve complete response (CR) or partial response (PR).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 25 monthsPopulation: Not collected.
Performed and summarized using descriptive statistics and graphical displays at pre and post treatment time points.
Outcome measures
Outcome data not reported
Adverse Events
Phase I Dose Level 1
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase I Dose Level -1
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase I Dose Level 1
n=2 participants at risk
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 1 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1.5 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase I Dose Level -1
n=1 participants at risk
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 0.5 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/2 • Up to 25 months
|
100.0%
1/1 • Number of events 1 • Up to 25 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Cardiac disorders
Heart failure
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Gastrointestinal disorders
Colitis
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Investigations
Ejection fraction decreased
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Cardiac disorders
Apical ballooning
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Vascular disorders
Hypotension
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
Other adverse events
| Measure |
Phase I Dose Level 1
n=2 participants at risk
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 1 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1.5 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Phase I Dose Level -1
n=1 participants at risk
Patients receive pembrolizumab 200 mg by infusion over 30 minutes on day 1 of each cycle and mogamulizumab 0.5 mg/kg by infusion over 60 minutes on days 1, 8, and 15 of the first cycle, then mogamulizumab 1 mg/kg by infusion on day 1 of subsequent cycles. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Investigations
Creatinine increased
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/2 • Up to 25 months
|
100.0%
1/1 • Number of events 1 • Up to 25 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Up to 25 months
|
100.0%
1/1 • Number of events 1 • Up to 25 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/2 • Up to 25 months
|
100.0%
1/1 • Number of events 2 • Up to 25 months
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Nervous system disorders
Dysarthia
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
100.0%
2/2 • Number of events 3 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Injury, poisoning and procedural complications
Fall
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 2 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
2/2 • Number of events 3 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
2/2 • Number of events 2 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 2 • Up to 25 months
|
100.0%
1/1 • Number of events 1 • Up to 25 months
|
|
General disorders
Chills
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Psychiatric disorders
Confusion
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
2/2 • Number of events 2 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
General disorders
Fever
|
100.0%
2/2 • Number of events 3 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
General disorders
Gait disturbance
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Psychiatric disorders
Hallucinations
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Cardiac disorders
High degree AV block
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/2 • Up to 25 months
|
100.0%
1/1 • Number of events 1 • Up to 25 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
2/2 • Number of events 3 • Up to 25 months
|
100.0%
1/1 • Number of events 1 • Up to 25 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Up to 25 months
|
100.0%
1/1 • Number of events 1 • Up to 25 months
|
|
Endocrine disorders
Hypothyroidism
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
100.0%
1/1 • Number of events 1 • Up to 25 months
|
|
Nervous system disorders
Lightheaded
|
0.00%
0/2 • Up to 25 months
|
100.0%
1/1 • Number of events 1 • Up to 25 months
|
|
Investigations
Lymphocyte count decreased
|
50.0%
1/2 • Number of events 2 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
100.0%
1/1 • Number of events 1 • Up to 25 months
|
|
General disorders
Non-cardiac chest pain
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Reproductive system and breast disorders
Penile bleeding
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • Up to 25 months
|
100.0%
1/1 • Number of events 1 • Up to 25 months
|
|
Metabolism and nutrition disorders
Polydipsia
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Nervous system disorders
Presyncope
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Cardiac disorders
Right bundle branch block
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Cardiac disorders
Sinus tachycardia
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
100.0%
1/1 • Number of events 1 • Up to 25 months
|
|
Infections and infestations
Upper respiratory infection
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Renal and urinary disorders
Urinary frequency
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Investigations
Weight loss
|
50.0%
1/2 • Number of events 2 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
|
Investigations
White blood cell count decreased
|
50.0%
1/2 • Number of events 1 • Up to 25 months
|
0.00%
0/1 • Up to 25 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60