Trial Outcomes & Findings for A Phase I/II Study of TRC105 in Metastatic Castrate Resistant Prostate Cancer (CRPC) (NCT NCT01090765)
NCT ID: NCT01090765
Last Updated: 2018-05-22
Results Overview
The MTD, to be administered in the phase II portion, is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%. TRC105 was administered at 20 mg/kg intravenous every two weeks until MTD was achieved.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
6 months
Results posted on
2018-05-22
Participant Flow
The study did not make it to the phase II (Arm 1-chemotherapy-naïve for metastatic disease (no prior antiangiogenic therapy) and Arm 2- post-docetaxel disease progression; evidence of disease progression despite prior docetaxel and bevacizumab) portion, thus no data is available for the phase II outcome measure "progression free survival".
Participant milestones
| Measure |
TRC105 1 mg/kg Every 2 Weeks
Intravenous infusion at 1 mg/kg every 2 weeks
|
TRC105 3 mg/kg Every 2 Weeks
Intravenous infusion at 3 mg/kg every 2 weeks
|
TRC105 10 mg/kg Every 2 Weeks
Intravenous infusion at 10 mg/kg every 2 weeks
|
TRC105 10 mg/kg Weekly
Intravenous infusion at 10 mg/kg weekly
|
TRC105 15 mg/kg Every 2 Weeks
Intravenous infusion at 15 mg/kg every 2 weeks
|
TRC105 20 mg/kg Every 2 Weeks
Intravenous infusion at 20 mg/kg every 2 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
2
|
6
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
1
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
TRC105 1 mg/kg Every 2 Weeks
Intravenous infusion at 1 mg/kg every 2 weeks
|
TRC105 3 mg/kg Every 2 Weeks
Intravenous infusion at 3 mg/kg every 2 weeks
|
TRC105 10 mg/kg Every 2 Weeks
Intravenous infusion at 10 mg/kg every 2 weeks
|
TRC105 10 mg/kg Weekly
Intravenous infusion at 10 mg/kg weekly
|
TRC105 15 mg/kg Every 2 Weeks
Intravenous infusion at 15 mg/kg every 2 weeks
|
TRC105 20 mg/kg Every 2 Weeks
Intravenous infusion at 20 mg/kg every 2 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
Patient withdrew consent
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Developed a DVT, needed anticoagulation
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Vasovagal reaction with first infusion
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Phase I/II Study of TRC105 in Metastatic Castrate Resistant Prostate Cancer (CRPC)
Baseline characteristics by cohort
| Measure |
TRC105 1 mg/kg Every 2 Weeks
n=3 Participants
Intravenous infusion at 1 mg/kg every 2 weeks
|
TRC105 3 mg/kg Every 2 Weeks
n=3 Participants
Intravenous infusion at 3 mg/kg every 2 weeks
|
TRC105 10 mg/kg Every 2 Weeks
n=3 Participants
Intravenous infusion at 10 mg/kg every 2 weeks
|
TRC105 10 mg/kg Weekly
n=2 Participants
Intravenous infusion at 10 mg/kg weekly
|
TRC105 15 mg/kg Every 2 Weeks
n=6 Participants
Intravenous infusion at 15 mg/kg every 2 weeks
|
TRC105 20 mg/kg Every 2 Weeks
n=4 Participants
Intravenous infusion at 20 mg/kg every 2 weeks
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 19.05 • n=5 Participants
|
62.37 years
STANDARD_DEVIATION 9.01 • n=7 Participants
|
66.53 years
STANDARD_DEVIATION 16.14 • n=5 Participants
|
63.15 years
STANDARD_DEVIATION 4.45 • n=4 Participants
|
65.83 years
STANDARD_DEVIATION 12.56 • n=21 Participants
|
61.8 years
STANDARD_DEVIATION 7.56 • n=10 Participants
|
64.32 years
STANDARD_DEVIATION 11.09 • 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
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 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
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
14 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
|
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
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
6 participants
n=21 Participants
|
4 participants
n=10 Participants
|
21 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe MTD, to be administered in the phase II portion, is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%. TRC105 was administered at 20 mg/kg intravenous every two weeks until MTD was achieved.
Outcome measures
| Measure |
TRC105 20 mg/kg Every 2 Weeks
n=21 Participants
Intravenous infusion at 20 mg/kg every 2 weeks
|
TRC105 3 mg/kg Every 2 Weeks
Intravenous infusion at 3 mg/kg every 2 weeks
|
TRC105 10 mg/kg Every 2 Weeks
Intravenous infusion at 10 mg/kg every 2 weeks
|
TRC105 10 mg/kg Weekly
Intravenous infusion at 10 mg/kg weekly
|
TRC105 15 mg/kg Every 2 Weeks
Intravenous infusion at 15 mg/kg every 2 weeks
|
TRC105 20 mg/kg Every 2 Weeks
Intravenous infusion at 20 mg/kg every 2 weeks
|
|---|---|---|---|---|---|---|
|
Phase I: Maximum Tolerated Dose (MTD) of TRC105 Given Every Two Weeks.
|
20 mg/kg every 2 weeks
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 43 months, 5 daysHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
TRC105 20 mg/kg Every 2 Weeks
n=3 Participants
Intravenous infusion at 20 mg/kg every 2 weeks
|
TRC105 3 mg/kg Every 2 Weeks
n=3 Participants
Intravenous infusion at 3 mg/kg every 2 weeks
|
TRC105 10 mg/kg Every 2 Weeks
n=3 Participants
Intravenous infusion at 10 mg/kg every 2 weeks
|
TRC105 10 mg/kg Weekly
n=2 Participants
Intravenous infusion at 10 mg/kg weekly
|
TRC105 15 mg/kg Every 2 Weeks
n=6 Participants
Intravenous infusion at 15 mg/kg every 2 weeks
|
TRC105 20 mg/kg Every 2 Weeks
n=4 Participants
Intravenous infusion at 20 mg/kg every 2 weeks
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: First 28 days on studyDose limiting toxicity is defined as any grade 3 or higher hematologic (excluding anemia) or non-hematologic toxicity considered to be possibly related to TRC105.
Outcome measures
| Measure |
TRC105 20 mg/kg Every 2 Weeks
n=3 Participants
Intravenous infusion at 20 mg/kg every 2 weeks
|
TRC105 3 mg/kg Every 2 Weeks
n=3 Participants
Intravenous infusion at 3 mg/kg every 2 weeks
|
TRC105 10 mg/kg Every 2 Weeks
n=3 Participants
Intravenous infusion at 10 mg/kg every 2 weeks
|
TRC105 10 mg/kg Weekly
n=2 Participants
Intravenous infusion at 10 mg/kg weekly
|
TRC105 15 mg/kg Every 2 Weeks
n=6 Participants
Intravenous infusion at 15 mg/kg every 2 weeks
|
TRC105 20 mg/kg Every 2 Weeks
n=4 Participants
Intravenous infusion at 20 mg/kg every 2 weeks
|
|---|---|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1- week intervals up to 6 monthsPSA decline (i.e., PSA greater than 4.0 ng/mL) is defined as two consecutively rising PSA values at a minimum of 1-week intervals (2.0 ng/mL is the minimum starting values for PSA). Normal PSA is 4.0 ng/mL or lower.
Outcome measures
| Measure |
TRC105 20 mg/kg Every 2 Weeks
n=3 Participants
Intravenous infusion at 20 mg/kg every 2 weeks
|
TRC105 3 mg/kg Every 2 Weeks
n=3 Participants
Intravenous infusion at 3 mg/kg every 2 weeks
|
TRC105 10 mg/kg Every 2 Weeks
n=3 Participants
Intravenous infusion at 10 mg/kg every 2 weeks
|
TRC105 10 mg/kg Weekly
n=2 Participants
Intravenous infusion at 10 mg/kg weekly
|
TRC105 15 mg/kg Every 2 Weeks
n=5 Participants
Intravenous infusion at 15 mg/kg every 2 weeks
|
TRC105 20 mg/kg Every 2 Weeks
n=4 Participants
Intravenous infusion at 20 mg/kg every 2 weeks
|
|---|---|---|---|---|---|---|
|
Prostatic-Specific Antigen (PSA) Decline
PSA Decline >4.0 ng/mL
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Prostatic-Specific Antigen (PSA) Decline
Normal PSA <4.0 ng/mL
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 56 days (one cycle = 28 days, restaging post cycle 2)Clinical response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% decrease in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
TRC105 20 mg/kg Every 2 Weeks
n=3 Participants
Intravenous infusion at 20 mg/kg every 2 weeks
|
TRC105 3 mg/kg Every 2 Weeks
n=3 Participants
Intravenous infusion at 3 mg/kg every 2 weeks
|
TRC105 10 mg/kg Every 2 Weeks
n=3 Participants
Intravenous infusion at 10 mg/kg every 2 weeks
|
TRC105 10 mg/kg Weekly
n=2 Participants
Intravenous infusion at 10 mg/kg weekly
|
TRC105 15 mg/kg Every 2 Weeks
n=6 Participants
Intravenous infusion at 15 mg/kg every 2 weeks
|
TRC105 20 mg/kg Every 2 Weeks
n=4 Participants
Intravenous infusion at 20 mg/kg every 2 weeks
|
|---|---|---|---|---|---|---|
|
Clinical Response
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Response
Stable Disease
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Clinical Response
Progressive Disease
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Clinical Response
Inevaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
TRC105 1 mg/kg Every 2 Weeks
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
TRC105 3 mg/kg Every 2 Weeks
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
TRC105 10 mg/kg Every 2 Weeks
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
TRC105 10 mg/kg Weekly
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
TRC105 15 mg/kg Every 2 Weeks
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
TRC105 20 mg/kg Every 2 Weeks
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TRC105 1 mg/kg Every 2 Weeks
n=3 participants at risk
Intravenous infusion at 1 mg/kg every 2 weeks
|
TRC105 3 mg/kg Every 2 Weeks
n=3 participants at risk
Intravenous infusion at 3 mg/kg every 2 weeks
|
TRC105 10 mg/kg Every 2 Weeks
n=3 participants at risk
Intravenous infusion at 10 mg/kg every 2 weeks
|
TRC105 10 mg/kg Weekly
n=2 participants at risk
Intravenous infusion at 10 mg/kg weekly
|
TRC105 15 mg/kg Every 2 Weeks
n=6 participants at risk
Intravenous infusion at 15 mg/kg every 2 weeks
|
TRC105 20 mg/kg Every 2 Weeks
n=4 participants at risk
Intravenous infusion at 20 mg/kg every 2 weeks
|
|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Investigations
CPK increased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
General disorders
Infusion related reaction
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
General disorders
Chills
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
General disorders
Fever
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
Other adverse events
| Measure |
TRC105 1 mg/kg Every 2 Weeks
n=3 participants at risk
Intravenous infusion at 1 mg/kg every 2 weeks
|
TRC105 3 mg/kg Every 2 Weeks
n=3 participants at risk
Intravenous infusion at 3 mg/kg every 2 weeks
|
TRC105 10 mg/kg Every 2 Weeks
n=3 participants at risk
Intravenous infusion at 10 mg/kg every 2 weeks
|
TRC105 10 mg/kg Weekly
n=2 participants at risk
Intravenous infusion at 10 mg/kg weekly
|
TRC105 15 mg/kg Every 2 Weeks
n=6 participants at risk
Intravenous infusion at 15 mg/kg every 2 weeks
|
TRC105 20 mg/kg Every 2 Weeks
n=4 participants at risk
Intravenous infusion at 20 mg/kg every 2 weeks
|
|---|---|---|---|---|---|---|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
100.0%
3/3 • Number of events 14 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
100.0%
2/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
2/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
75.0%
3/4 • Number of events 7 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
100.0%
3/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
General disorders
Chills
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
100.0%
3/3 • Number of events 13 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
2/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Investigations
Fibrinogen decreased
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
2/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
100.0%
3/3 • Number of events 9 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
3/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
75.0%
3/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
General disorders
Infusion related reaction
|
66.7%
2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Nervous system disorders
Memory impairment
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
100.0%
2/2 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
2/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify (initiating urination)
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Renal and urinary disorders
Urinary tract obstruction
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Investigations
Weight gain
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
100.0%
2/2 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Investigations
CPK increased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
4/6 • Number of events 7 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify (black tarry stools)
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
General disorders
Malaise
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify (petechiae)
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Investigations
Weight loss
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Vascular disorders
Hot flashes
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify (gastroenteritis)
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 43 months, 5 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place