Trial Outcomes & Findings for A Parallel Arm Phase 1b/2a Study of DKN-01 as Monotherapy or in Combination With Docetaxel for the Treatment of Advanced Prostate Cancer With Elevated DKK1 (NCT NCT03837353)
NCT ID: NCT03837353
Last Updated: 2023-12-18
Results Overview
Measured among Phase I dose-escalation cohorts (arms 1A.1, 1A.2, 2A.1, and 2A.2) only.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Up to End of Cycle 1 (Up to Day 21 for Cohort 1A, Up to Day 28 for Cohort 2A)
Results posted on
2023-12-18
Participant Flow
Participant milestones
| Measure |
Cohort 1A.1 (DKN-01 300mg, Docetaxel 75 mg/m2)
Participants in the dose-escalation Cohort 1A.1 who received DKN-01 300mg and Docetaxel 75 mg/m2.
|
Cohort 1A.2 (DKN-01 600mg, Docetaxel 75 mg/m2)
Participants in the dose-escalation Cohort 1A.2 who received DKN-01 600mg and Docetaxel 75 mg/m2.
|
Cohort 1B (DKN-01 600mg [Phase II Dose], Docetaxel 75 mg/m2)
Participants in the Phase II dose-expansion Cohort 1B who received DKN-01 600mg \[Phase II Dose\] and Docetaxel 75 mg/m2.
|
Cohort 2A.1 (DKN-01 300mg)
Participants in dose-escalation Cohort 2A.1 who received DKN-01 300mg monotherapy.
|
Cohort 2A.2 (DKN-01 600mg)
Participants in dose-escalation Cohort 2A.1 who received DKN-01 600mg monotherapy.
|
Cohort 2B (DKN-01 600mg [Phase 2 Dose])
Participants in the Phase II dose-expansion Cohort 2B who received DKN-01 600mg \[Phase II Dose\] monotherapy.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
2
|
4
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
2
|
4
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Parallel Arm Phase 1b/2a Study of DKN-01 as Monotherapy or in Combination With Docetaxel for the Treatment of Advanced Prostate Cancer With Elevated DKK1
Baseline characteristics by cohort
| Measure |
Cohort 1A.1 (DKN-01 300mg, Docetaxel 75 mg/m2)
n=3 Participants
Participants in the dose-escalation Cohort 1A.1 who received DKN-01 300mg and Docetaxel 75 mg/m2.
|
Cohort 1A.2 (DKN-01 600mg, Docetaxel 75 mg/m2)
n=3 Participants
Participants in the dose-escalation Cohort 1A.2 who received DKN-01 600mg and Docetaxel 75 mg/m2.
|
Cohort 1B (DKN-01 600mg [Phase II Dose], Docetaxel 75 mg/m2)
n=2 Participants
Participants in the Phase II dose-expansion Cohort 1B who received DKN-01 600mg \[Phase II Dose\] and Docetaxel 75 mg/m2.
|
Cohort 2A.1 (DKN-01 300mg)
n=4 Participants
Participants in dose-escalation Cohort 2A.1 who received DKN-01 300mg monotherapy.
|
Cohort 2A.2 (DKN-01 600mg)
n=3 Participants
Participants in dose-escalation Cohort 2A.1 who received DKN-01 600mg monotherapy.
|
Cohort 2B (DKN-01 600mg [Phase 2 Dose])
n=3 Participants
Participants in the Phase II dose-expansion Cohort 2B who received DKN-01 600mg \[Phase II Dose\] monotherapy.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
68 years
n=7 Participants
|
76 years
n=5 Participants
|
65 years
n=4 Participants
|
74 years
n=21 Participants
|
64 years
n=10 Participants
|
70 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
18 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=10 Participants
|
18 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to End of Cycle 1 (Up to Day 21 for Cohort 1A, Up to Day 28 for Cohort 2A)Measured among Phase I dose-escalation cohorts (arms 1A.1, 1A.2, 2A.1, and 2A.2) only.
Outcome measures
| Measure |
Cohort 1A.1 (DKN-01 300mg, Docetaxel 75 mg/m2)
n=3 Participants
Participants in the dose-escalation Cohort 1A.1 who received DKN-01 300mg and Docetaxel 75 mg/m2.
|
Cohort 1A.2 (DKN-01 600mg, Docetaxel 75 mg/m2)
n=3 Participants
Participants in the dose-escalation Cohort 1A.2 who received DKN-01 600mg and Docetaxel 75 mg/m2.
|
Cohort 2A.1 (DKN-01 300mg)
n=4 Participants
Participants in dose-escalation Cohort 2A.1 who received DKN-01 300mg monotherapy.
|
Cohort 2A.2 (DKN-01 600mg)
n=3 Participants
Participants in dose-escalation Cohort 2A.1 who received DKN-01 600mg monotherapy.
|
Cohort 2A.2 (DKN-01 600mg)
Participants in dose-escalation Cohort 2A.1 who received DKN-01 600mg monotherapy.
|
Cohort 2B (DKN-01 600mg [Phase 2 Dose])
Participants in the Phase II dose-expansion Cohort 2B who received DKN-01 600mg \[Phase II Dose\] monotherapy.
|
|---|---|---|---|---|---|---|
|
Number of Dose Limiting Toxicities Observed by End of Treatment Cycle 1
|
0 Number of events
Standard Deviation 0
|
0 Number of events
Standard Deviation 0
|
0 Number of events
Standard Deviation 0
|
0 Number of events
Standard Deviation 0
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Year 2 Post-BaselineiRECIST will be used by the Investigator to assess tumor response and progression. An iCR is defined as the disappearance of all target lesions as assessed by iRECIST; an iPR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, as assessed by iRECIST.
Outcome measures
| Measure |
Cohort 1A.1 (DKN-01 300mg, Docetaxel 75 mg/m2)
n=3 Participants
Participants in the dose-escalation Cohort 1A.1 who received DKN-01 300mg and Docetaxel 75 mg/m2.
|
Cohort 1A.2 (DKN-01 600mg, Docetaxel 75 mg/m2)
n=3 Participants
Participants in the dose-escalation Cohort 1A.2 who received DKN-01 600mg and Docetaxel 75 mg/m2.
|
Cohort 2A.1 (DKN-01 300mg)
n=2 Participants
Participants in dose-escalation Cohort 2A.1 who received DKN-01 300mg monotherapy.
|
Cohort 2A.2 (DKN-01 600mg)
n=4 Participants
Participants in dose-escalation Cohort 2A.1 who received DKN-01 600mg monotherapy.
|
Cohort 2A.2 (DKN-01 600mg)
n=3 Participants
Participants in dose-escalation Cohort 2A.1 who received DKN-01 600mg monotherapy.
|
Cohort 2B (DKN-01 600mg [Phase 2 Dose])
n=3 Participants
Participants in the Phase II dose-expansion Cohort 2B who received DKN-01 600mg \[Phase II Dose\] monotherapy.
|
|---|---|---|---|---|---|---|
|
Number of Participants With a Best Overall Response of Complete Response (iCR) or Partial Response (iPR) Per iRECIST by End of Long-Term Follow-Up Period
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Year 2 Post-BaselinePopulation: Data for this outcome measure was not collected among participants in the Monotherapy arms (2A.1, 2A.2, and 2B).
Defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue as assessed by Investigator using iRECIST, in bone as assessed by Investigator using Prostate Cancer Working Group 3 (PCWG3), or death, whichever occurs first.
Outcome measures
| Measure |
Cohort 1A.1 (DKN-01 300mg, Docetaxel 75 mg/m2)
n=3 Participants
Participants in the dose-escalation Cohort 1A.1 who received DKN-01 300mg and Docetaxel 75 mg/m2.
|
Cohort 1A.2 (DKN-01 600mg, Docetaxel 75 mg/m2)
n=3 Participants
Participants in the dose-escalation Cohort 1A.2 who received DKN-01 600mg and Docetaxel 75 mg/m2.
|
Cohort 2A.1 (DKN-01 300mg)
n=2 Participants
Participants in dose-escalation Cohort 2A.1 who received DKN-01 300mg monotherapy.
|
Cohort 2A.2 (DKN-01 600mg)
Participants in dose-escalation Cohort 2A.1 who received DKN-01 600mg monotherapy.
|
Cohort 2A.2 (DKN-01 600mg)
Participants in dose-escalation Cohort 2A.1 who received DKN-01 600mg monotherapy.
|
Cohort 2B (DKN-01 600mg [Phase 2 Dose])
Participants in the Phase II dose-expansion Cohort 2B who received DKN-01 600mg \[Phase II Dose\] monotherapy.
|
|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
6.3 Months
Interval 5.1 to 6.6
|
8.1 Months
Interval 4.2 to 8.5
|
2 Months
Interval 1.2 to 2.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Year 2 Post-BaselineOutcome measures
| Measure |
Cohort 1A.1 (DKN-01 300mg, Docetaxel 75 mg/m2)
n=3 Participants
Participants in the dose-escalation Cohort 1A.1 who received DKN-01 300mg and Docetaxel 75 mg/m2.
|
Cohort 1A.2 (DKN-01 600mg, Docetaxel 75 mg/m2)
n=3 Participants
Participants in the dose-escalation Cohort 1A.2 who received DKN-01 600mg and Docetaxel 75 mg/m2.
|
Cohort 2A.1 (DKN-01 300mg)
n=2 Participants
Participants in dose-escalation Cohort 2A.1 who received DKN-01 300mg monotherapy.
|
Cohort 2A.2 (DKN-01 600mg)
n=4 Participants
Participants in dose-escalation Cohort 2A.1 who received DKN-01 600mg monotherapy.
|
Cohort 2A.2 (DKN-01 600mg)
n=3 Participants
Participants in dose-escalation Cohort 2A.1 who received DKN-01 600mg monotherapy.
|
Cohort 2B (DKN-01 600mg [Phase 2 Dose])
n=3 Participants
Participants in the Phase II dose-expansion Cohort 2B who received DKN-01 600mg \[Phase II Dose\] monotherapy.
|
|---|---|---|---|---|---|---|
|
Number of Participants With a Decline in Prostate-Specific Antigen (PSA) of at Least 50% Relative to Baseline
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Year 2 Post-BaselineOutcome measures
| Measure |
Cohort 1A.1 (DKN-01 300mg, Docetaxel 75 mg/m2)
n=3 Participants
Participants in the dose-escalation Cohort 1A.1 who received DKN-01 300mg and Docetaxel 75 mg/m2.
|
Cohort 1A.2 (DKN-01 600mg, Docetaxel 75 mg/m2)
n=3 Participants
Participants in the dose-escalation Cohort 1A.2 who received DKN-01 600mg and Docetaxel 75 mg/m2.
|
Cohort 2A.1 (DKN-01 300mg)
n=2 Participants
Participants in dose-escalation Cohort 2A.1 who received DKN-01 300mg monotherapy.
|
Cohort 2A.2 (DKN-01 600mg)
n=4 Participants
Participants in dose-escalation Cohort 2A.1 who received DKN-01 600mg monotherapy.
|
Cohort 2A.2 (DKN-01 600mg)
n=3 Participants
Participants in dose-escalation Cohort 2A.1 who received DKN-01 600mg monotherapy.
|
Cohort 2B (DKN-01 600mg [Phase 2 Dose])
n=3 Participants
Participants in the Phase II dose-expansion Cohort 2B who received DKN-01 600mg \[Phase II Dose\] monotherapy.
|
|---|---|---|---|---|---|---|
|
Maximal Percent Change in PSA Measured After Treatment Initiation
|
-74 Percentage
Interval -94.0 to -57.0
|
-87 Percentage
Interval -100.0 to -23.0
|
0 Percentage
Interval -45.0 to 40.0
|
93 Percentage
Interval -8.0 to 317.0
|
57 Percentage
Interval 6.0 to 78.0
|
28 Percentage
Interval 17.0 to 174.0
|
Adverse Events
DKN-01 300mg, Docetaxel 75 mg/m2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
DKN-01 600mg, Docetaxel 75 mg/m2
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
DKN-01 300mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
DKN-01 600mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DKN-01 300mg, Docetaxel 75 mg/m2
n=3 participants at risk
Participants who received DKN-01 300mg and Docetaxel 75 mg/m2.
|
DKN-01 600mg, Docetaxel 75 mg/m2
n=5 participants at risk
Participants who received DKN-01 600mg and Docetaxel 75 mg/m2.
|
DKN-01 300mg
n=4 participants at risk
Participants who received DKN-01 300mg monotherapy.
|
DKN-01 600mg
n=6 participants at risk
Participants who received DKN-01 600mg monotherapy.
|
|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Infections and infestations
Clostridium Difficile (Serious Adverse Event)
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Spinal Fracture
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
Other adverse events
| Measure |
DKN-01 300mg, Docetaxel 75 mg/m2
n=3 participants at risk
Participants who received DKN-01 300mg and Docetaxel 75 mg/m2.
|
DKN-01 600mg, Docetaxel 75 mg/m2
n=5 participants at risk
Participants who received DKN-01 600mg and Docetaxel 75 mg/m2.
|
DKN-01 300mg
n=4 participants at risk
Participants who received DKN-01 300mg monotherapy.
|
DKN-01 600mg
n=6 participants at risk
Participants who received DKN-01 600mg monotherapy.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Hepatobiliary disorders
alanine transaminase (ALT) levels increased
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
40.0%
2/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Hepatobiliary disorders
Alkaline Phosphatase (ALP) Levels Increased
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
25.0%
1/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
General disorders
Alopecia
|
100.0%
3/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
40.0%
2/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
General disorders
Anorexia
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
40.0%
2/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
25.0%
1/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
33.3%
2/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
40.0%
2/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Hepatobiliary disorders
Aspartate aminotransferase (AST) levels increased
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
40.0%
2/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
25.0%
1/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
60.0%
3/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
50.0%
2/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
66.7%
4/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Hepatobiliary disorders
Blood bilirubin increased
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Eye disorders
Blurred Vision
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
25.0%
1/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Cardiac disorders
Cardiac disorders
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
25.0%
1/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
General disorders
Chills
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
40.0%
2/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Nervous system disorders
Confusion
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
25.0%
1/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
33.3%
2/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Creatine phosphokinase (CPK) levels increased
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Renal and urinary disorders
Creatinine increased
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
General disorders
Dehydration
|
66.7%
2/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
40.0%
2/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Gastrointestinal disorders
Dysgeusia
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
40.0%
2/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Renal and urinary disorders
Dysuria
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Edema limbs
|
66.7%
2/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
25.0%
1/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Blood and lymphatic system disorders
Epistaxis
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
40.0%
2/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
General disorders
Fall
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
General disorders
Fatigue
|
66.7%
2/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
80.0%
4/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
75.0%
3/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
50.0%
3/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Gastrointestinal disorders
Fecal Incontinence
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
General disorders
Fever
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Nervous system disorders
Gait disturbance
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Gastrointestinal disorders
Gastroeosphgeal Reflux
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
General disorders
General Disorders and Administrative Site Condition
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
33.3%
2/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Renal and urinary disorders
Hypocalcemia
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Renal and urinary disorders
Hypokalemia
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Renal and urinary disorders
Hypomagnesemia
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Cardiac disorders
Hypotension
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
General disorders
Insomnia
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
40.0%
2/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Localized edema
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Mucositis oral
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/connective tissue disorder
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
75.0%
3/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
33.3%
2/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
40.0%
2/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
40.0%
2/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
25.0%
1/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
60.0%
3/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
25.0%
1/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
83.3%
5/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Nervous system disorders
Nervous system disorders
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
2/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
40.0%
2/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Infections and infestations
Penile infection
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
60.0%
3/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
33.3%
2/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Vascular disorders
Phlebitis
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
25.0%
1/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
General disorders
Pruritus
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
40.0%
2/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
40.0%
2/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Gastrointestinal disorders
Rectal mucositis
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
25.0%
1/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
General disorders
Surgical and Medical procedure
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Vascular disorders
Thromboembolic event
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
25.0%
1/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
16.7%
1/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Renal and urinary disorders
Urinary tract pain
|
33.3%
1/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
25.0%
1/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Vascular disorders
Vascular Disorder
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
33.3%
2/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Eye disorders
Watering eyes
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
|
Blood and lymphatic system disorders
White Blood Cells Decreased
|
0.00%
0/3 • 40 months
PI to monitor for AEs at every follow-up visit.
|
20.0%
1/5 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/4 • 40 months
PI to monitor for AEs at every follow-up visit.
|
0.00%
0/6 • 40 months
PI to monitor for AEs at every follow-up visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place