Trial Outcomes & Findings for A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects With Advanced Solid Tumors (NCT NCT00816361)
NCT ID: NCT00816361
Last Updated: 2019-03-04
Results Overview
AEs were any unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of MEDI-573, whether or not considered related to MEDI-573. A SAE was any AE that resulted in: death; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; was life-threatening; was a congenital anomaly/birth defect in the offspring of a study participant; or was an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above. TEAEs were defined as AEs present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, up to 30 days after the last dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
43 participants
Primary outcome timeframe
From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 years
Results posted on
2019-03-04
Participant Flow
A total of 43 participants ((23 participants in dose-escalation phase and 20 participants in dose-expansion phase) were entered in the study and received the study treatment.
Participant milestones
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
4
|
3
|
3
|
3
|
3
|
10
|
10
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
3
|
3
|
2
|
3
|
3
|
9
|
10
|
Reasons for withdrawal
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
2
|
1
|
|
Overall Study
Death
|
4
|
3
|
3
|
3
|
1
|
1
|
3
|
7
|
8
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=14 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=13 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
TOTAL
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Age, Continuous
|
53.8 Years
STANDARD_DEVIATION 12.2 • n=99 Participants
|
67.0 Years
STANDARD_DEVIATION 8.7 • n=107 Participants
|
64.5 Years
STANDARD_DEVIATION 13.7 • n=206 Participants
|
68.0 Years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
61.2 Years
STANDARD_DEVIATION 8.6 • n=31 Participants
|
58.3 Years
STANDARD_DEVIATION 18.5 • n=30 Participants
|
65.7 Years
STANDARD_DEVIATION 4.5 • n=3 Participants
|
62.6 Years
STANDARD_DEVIATION 11.5 • n=6 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
18 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
25 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
42 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
39 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 yearsPopulation: The Safety Population included all participants who had received any MEDI-573 treatment.
AEs were any unfavorable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with the use of MEDI-573, whether or not considered related to MEDI-573. A SAE was any AE that resulted in: death; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity; was life-threatening; was a congenital anomaly/birth defect in the offspring of a study participant; or was an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes above. TEAEs were defined as AEs present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, up to 30 days after the last dose.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=14 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=13 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
TEAEs
|
4 Participants
|
3 Participants
|
13 Participants
|
3 Participants
|
13 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
Treatment emergent SAEs
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 yearsPopulation: The Safety Population included all participants who had received any MEDI-573 treatment.
An abnormal laboratory finding that was judged by the investigator to be medically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573, or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=14 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=13 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Blood lactate dehydrogenase increased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Lipase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Anemia
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Leukopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Lymphopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Red blood cell count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
White blood cell count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
White blood cell count increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Blood alkaline phosphatase increased
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Aspartate aminotransferase increased
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Weight decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Blood creatine increased
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Blood bilirubin increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Breath sounds abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Cardiac enzymes increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Electrocardiogram QT prolonged
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Glomerular filtration rate decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Heart rate increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Protein total increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Weight increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Hematuria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Renal failure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Thrombocytopenia
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Alanine aminotransferase increased
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Blood creatinine increased
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Blood insulin increased
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Blood growth hormone increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 yearsPopulation: The Safety Population included all participants who had received any MEDI-573 treatment.
Vital signs and physical findings included parameters such as heart rate, blood pressure, temperature, and respiratory rate. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-573 or events absent at baseline that emerged after administration of MEDI-573, for the period extending to 30 days after the last dose.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=14 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=13 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as TEAEs
Tachycardia
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as TEAEs
Breath sounds abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as TEAEs
Heart rate increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as TEAEs
Hypertension
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as TEAEs
Orthostatic hypotension
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as TEAEs
Pyrexia
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as TEAEs
Hypotension
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 through Cycle 1 Day 21Population: MTD Evaluable Population included all participants in dose-escalation phase who had received at least 1 full cycle of MEDI-573 and completed safety follow-up through DLT period (Cycle 1 Day 1 through Cycle 1 Day 21), or who experienced a DLT. Two participants did not receive a full cycle of MEDI-573 and therefore excluded from MTD population.
The MTD was defined as the highest dose that can be safely administered to participants and was determined by the number of participants in each cohort with a dose-limiting toxicity (DLT). The number and proportion of participants in each dose cohort and the number of participants with a DLT was presented using the total number of participants in the MTD Evaluable Population as the denominator. 2 participants from Cohorts 0.5 and 5 mg/kg QWk (1 in each cohort) did not complete the DLT period and therefore not evaluable for MTD.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=21 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of MEDI-573
|
NA mg/kg
The MTD was not established in the study.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 through Cycle 1 Day 21Population: The Safety Population included all participants who had received any MEDI-573 treatment.
A DLT was defined as any grade greater than or equal to (\>=) 3 treatment-related non-hematologic toxicity that occurred during the DLT assessment period with the following exceptions: Grade less than (\<) 4 serum-high glucose (fasting) with duration of \< 24 hours; Grade 3 fever (in the absence of neutropenia) defined as \> 40.0 degree centigrade (°C) \[greater than (\>) 104.0°F\] that resolved to normal or baseline within 24 hours of treatment and was not considered an SAE; or Grade 3 rigors/chills that responded to optimal therapy; any Grade \>= 3 treatment-related hematologic toxicity that occurred during the DLT assessment period.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=14 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=13 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 yearsPopulation: Safety population: Participants in the dose-escalation phase were analyzed for this outcome measure.
The OBED was defined as the dose at which all circulating insulin-like growth factor (IGF)-1 and IGF-2 ligand was sequestered by MEDI-573.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=23 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Optimal Biologically Effective Dose (OBED) of MEDI-573
|
5 mg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15Population: The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.
The Cmax was the maximum observed serum concentration of MEDI-573.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=4 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=3 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
n=10 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
n=9 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) After the First Dose
|
11.6 microgram per milliliter (mcg/mL)
Standard Deviation 5.54
|
71.8 microgram per milliliter (mcg/mL)
Standard Deviation 12.5
|
166 microgram per milliliter (mcg/mL)
Standard Deviation 37.7
|
264 microgram per milliliter (mcg/mL)
Standard Deviation 121
|
560 microgram per milliliter (mcg/mL)
Standard Deviation 251
|
588 microgram per milliliter (mcg/mL)
Standard Deviation 213
|
1200 microgram per milliliter (mcg/mL)
Standard Deviation 621
|
115 microgram per milliliter (mcg/mL)
Standard Deviation 42.6
|
412 microgram per milliliter (mcg/mL)
Standard Deviation 141
|
SECONDARY outcome
Timeframe: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15Population: The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.
The tmax was defined as actual sampling time to reach the maximum observed serum concentration of MEDI-573.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=4 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=3 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
n=10 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
n=9 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Concentration (Tmax) After the First Dose
|
0.04 Day
Interval 0.04 to 0.04
|
0.04 Day
Interval 0.04 to 0.06
|
0.04 Day
Interval 0.04 to 0.12
|
0.04 Day
Interval 0.04 to 0.14
|
0.28 Day
Interval 0.12 to 0.3
|
0.06 Day
Interval 0.06 to 0.06
|
0.06 Day
Interval 0.06 to 0.06
|
0.04 Day
Interval 0.04 to 0.3
|
0.06 Day
Interval 0.04 to 0.3
|
SECONDARY outcome
Timeframe: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15Population: The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.
The Ctrough was the lowest serum concentration of MEDI-573 within a dosing interval.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=2 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=3 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=3 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
n=10 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
n=9 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Trough Serum Concentration (Ctrough) After the First Dose
|
1.04 mcg/mL
Standard Deviation 0.919
|
1.98 mcg/mL
Standard Deviation 0.377
|
17.3 mcg/mL
Standard Deviation 10.2
|
34.6 mcg/mL
Standard Deviation 26.8
|
138 mcg/mL
Standard Deviation 77.8
|
32.9 mcg/mL
Standard Deviation 28.2
|
63.5 mcg/mL
Standard Deviation 59.5
|
5.27 mcg/mL
Standard Deviation 4.80
|
77.8 mcg/mL
Standard Deviation 33.5
|
SECONDARY outcome
Timeframe: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15Population: The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.
The Cmax/dose was the dose-normalized maximum serum concentration of MEDI-573.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=4 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=3 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
n=10 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
n=9 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Dose Normalized Cmax (Cmax/Dose) After the First Dose
|
0.319 mcg/mL/mg
Standard Deviation 0.154
|
0.593 mcg/mL/mg
Standard Deviation 0.122
|
0.401 mcg/mL/mg
Standard Deviation 0.054
|
0.393 mcg/mL/mg
Standard Deviation 0.129
|
0.422 mcg/mL/mg
Standard Deviation 0.168
|
0.240 mcg/mL/mg
Standard Deviation 0.072
|
0.352 mcg/mL/mg
Standard Deviation 0.178
|
0.267 mcg/mL/mg
Standard Deviation 0.110
|
0.314 mcg/mL/mg
Standard Deviation 0.095
|
SECONDARY outcome
Timeframe: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15Population: The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.
Area under the serum concentration-time curve over the first dosing interval.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=2 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=3 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=3 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
n=10 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
n=9 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve Over the First Dosing Interval (AUCτ)
|
9.59 mcg*day/mL
Standard Deviation 5.12
|
90.8 mcg*day/mL
Standard Deviation 18.6
|
431 mcg*day/mL
Standard Deviation 135
|
631 mcg*day/mL
Standard Deviation 288
|
1950 mcg*day/mL
Standard Deviation 917
|
3510 mcg*day/mL
Standard Deviation 1230
|
5790 mcg*day/mL
Standard Deviation 3390
|
227 mcg*day/mL
Standard Deviation 99.8
|
1280 mcg*day/mL
Standard Deviation 392
|
SECONDARY outcome
Timeframe: For weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); For 3 weekly dosing: Pre- and post-infusion (0, 2, 6, 24, and 48 hours post-infusion); and on Days 8 and 15Population: The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.
The AUCtau/dose was a measure of dose-normalized area under the serum concentration-time curve over the first dosing interval.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=2 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=3 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=3 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
n=10 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
n=9 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Dose-normalized Area Under the Serum Concentration Time Curve Over the First Dosing Interval (AUCτ/Dose)
|
0.245 mcg*day/mL/mg
Standard Deviation 0.145
|
0.749 mcg*day/mL/mg
Standard Deviation 0.176
|
0.962 mcg*day/mL/mg
Standard Deviation 0.041
|
0.955 mcg*day/mL/mg
Standard Deviation 0.401
|
1.47 mcg*day/mL/mg
Standard Deviation 0.624
|
1.46 mcg*day/mL/mg
Standard Deviation 0.526
|
1.70 mcg*day/mL/mg
Standard Deviation 0.976
|
0.53 mcg*day/mL/mg
Standard Deviation 0.233
|
0.981 mcg*day/mL/mg
Standard Deviation 0.275
|
SECONDARY outcome
Timeframe: Pre-infusion on Day 1 of each cycle, end of treatment, and 90 days after last dose MEDI-573 (up to 3.5 years)Population: The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" is number of participants analyzed for this outcome measure.
Two methods were used to assess the immunogenicity data: an ECL-based method and measurement of neutralizing ADA. The titer was calculated by multiplying the minimum assay dilution factor by the reciprocal of the highest dilution factor which yielded an ECL multiple equal to or greater than the screening assay cut-point factor.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=4 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=3 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
n=10 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
n=9 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI-573
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From study entry through the end of the study, up to 3.5 yearsPopulation: The Efficacy Evaluable Population included all participants who received MEDI-573 and had at least one tumor assessment after the initiation of treatment. Participants in the dose-expansion phase were to have at least 1 lesion that was measurable using RECIST criteria, and a histologically confirmed diagnosis of advanced urothelial carcinoma.
The ORR was defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) according to the RECIST criteria The CR was defined as disappearance of all target and nontarget lesions and no new lesions; and PR was definded as \>= 30% decrease in the sum of diameters of Target Lesions (compared to baseline \[screening\]) and no new lesions.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=13 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=12 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=1 Participants
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry through the end of the study, up to 3.5 yearsPopulation: Efficacy Evaluable Population included all participants who received MEDI-573 and had at least 1 tumor assessment after initiation of treatment. Participants in dose-expansion phase had at least 1 measurable lesion and histologically diagnosis of advanced urothelial carcinoma. Here, "N" is number of participants analyzed for this outcome measure.
Progression-free survival (PFS) was defined as the duration from the start of treatment with MEDI-573 until the documentation of disease progression or death due to any cause, whichever occurred first.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=12 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=11 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=1 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
1.0 Months
Interval 0.5 to 1.5
|
2.6 Months
Interval 1.3 to 2.8
|
1.4 Months
Interval 1.2 to 2.8
|
1.5 Months
Interval 0.7 to 4.7
|
1.3 Months
Interval 0.7 to 4.2
|
NA Months
Interval 1.2 to
Median and upper limit of 95 % confidence interval was not applicable, as only 1 participant was evaluable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry through the end of the study, up to 3.5 yearsPopulation: Efficacy Evaluable Population included all participants who received MEDI-573 and had at least 1 tumor assessment after initiation of treatment. Participants in dose-expansion phase had at least 1 measurable lesion and histologically diagnosis of advanced urothelial carcinoma. Here, "N" is number of participants analyzed for this outcome measure.
Time to disease progression (TTP) was defined as the duration from the start of treatment with MEDI-573 until the documentation of disease progression.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=12 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=11 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=1 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Progression
|
1.0 Months
Interval 0.5 to 1.5
|
2.6 Months
Interval 1.3 to 2.8
|
1.4 Months
Interval 1.2 to 2.8
|
1.5 Months
Interval 0.7 to 4.7
|
1.3 Months
Interval 0.7 to 4.2
|
NA Months
Interval 1.2 to
Median and upper limit of 95 % confidence interval was not applicable, as only 1 participant was evaluable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry through the end of the study, up to 3.5 yearsPopulation: Efficacy Evaluable Population included all participants who received MEDI-573 and had at least 1 tumor assessment after initiation of treatment. Participants in dose-expansion phase had at least 1 measurable lesion and histologically diagnosis of advanced urothelial carcinoma. Here, "N" is number of participants analyzed for this outcome measure.
Overall survival (OS) was defined as the time from the start of treatment with MEDI-573 until death.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=9 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=9 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=1 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=1 Participants
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival
|
5.3 Months
Interval 2.1 to 8.7
|
13.6 Months
Interval 1.9 to 20.2
|
12.3 Months
Interval 1.4 to 37.3
|
2.5 Months
Interval 1.3 to 8.6
|
4.0 Months
Interval 1.1 to 33.0
|
7.9 Months
Interval 1.4 to 7.9
|
4.7 Months
Interval 4.7 to 4.7
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry through the end of the study, up to 3.5 yearsPopulation: Participants in efficacy evaluable population and who achieved objective response were analyzed. As no participants achieved objective response in this study, number of participants analyzed for this outcome measure were zero.
Time to response was defined as the duration from the start of treatment with MEDI-573 to the first documentation of objective response (confirmed CR or PR) and was only assessed in participants who had achieved objective response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From study entry through the end of the study, up to 3.5 yearsPopulation: Participants in efficacy evaluable population and who achieved objective response were analyzed. As no participants achieved objective response in this study, number of participants analyzed for this outcome measure were zero.
Duration of response was defined as the duration from the first documentation of objective response (confirmed CR or PR) to the first documented disease progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the start of study treatment through 30 days after the last dose of MEDI-573, up to 3.5 yearsPopulation: The Safety Population included all participants who had received any MEDI-573 treatment. Here, "N" and "n" represent number of participants analyzed for this outcome measure and at specific time points, respectively.
The suppression profiles of both IGF-1 and IGF-2 post administration of MEDI-573 in relation to time course of antibody concentrations in serum were evaluated during treatment.
Outcome measures
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 Participants
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=4 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 Participants
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=3 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=3 Participants
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Expansion
n=10 Participants
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Expansion
n=9 Participants
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|---|---|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-II at 1.000
|
1.060 nanogram per milliliter (ng/ml)
Standard Deviation 0.828
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-II at 7.000
|
—
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-II at 7.042
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-I at 0.000
|
4.014 nanogram per milliliter (ng/ml)
Standard Deviation 2.177
|
9.264 nanogram per milliliter (ng/ml)
Standard Deviation 7.401
|
4.655 nanogram per milliliter (ng/ml)
Standard Deviation 3.437
|
1.721 nanogram per milliliter (ng/ml)
Standard Deviation 2.710
|
1.440 nanogram per milliliter (ng/ml)
Standard Deviation 0.812
|
2.693 nanogram per milliliter (ng/ml)
Standard Deviation 2.855
|
1.925 nanogram per milliliter (ng/ml)
Standard Deviation 1.374
|
1.749 nanogram per milliliter (ng/ml)
Standard Deviation 0.643
|
2.099 nanogram per milliliter (ng/ml)
Standard Deviation 1.128
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-I at 0.042
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-I at 0.125
|
0.252 nanogram per milliliter (ng/ml)
Standard Deviation 0.111
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-I at 0.292
|
0.345 nanogram per milliliter (ng/ml)
Standard Deviation 0.227
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-I at 1.000
|
2.088 nanogram per milliliter (ng/ml)
Standard Deviation 0.964
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
0.215 nanogram per milliliter (ng/ml)
Standard Deviation 0.117
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-I at 7.000
|
—
|
—
|
—
|
0.223 nanogram per milliliter (ng/ml)
Standard Deviation 0.115
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
0.641 nanogram per milliliter (ng/ml)
Standard Deviation 0.546
|
0.196 nanogram per milliliter (ng/ml)
Standard Deviation 0.078
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-I at 7.042
|
0.201 nanogram per milliliter (ng/ml)
Standard Deviation 0.087
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-II at 0.000
|
2.773 nanogram per milliliter (ng/ml)
Standard Deviation 0.320
|
2.984 nanogram per milliliter (ng/ml)
Standard Deviation 1.753
|
2.431 nanogram per milliliter (ng/ml)
Standard Deviation 0.139
|
1.879 nanogram per milliliter (ng/ml)
Standard Deviation 1.020
|
1.872 nanogram per milliliter (ng/ml)
Standard Deviation 0.862
|
2.780 nanogram per milliliter (ng/ml)
Standard Deviation 0.694
|
4.093 nanogram per milliliter (ng/ml)
Standard Deviation 1.039
|
2.689 nanogram per milliliter (ng/ml)
Standard Deviation 0.882
|
2.213 nanogram per milliliter (ng/ml)
Standard Deviation 0.752
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-II at 0.042
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-II at 0.125
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL)
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL)
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL)
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL)
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL)
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL)
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL)
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-II at 0.292
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-II at 14.000
|
—
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-II at 14.042
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-II at 21.000
|
—
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation NA
Mean was below the limit of quantitation (0.626 ng/mL). Standard deviation can not be calculated as only one participant evaluated.
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-I at 0.063
|
—
|
—
|
—
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
—
|
—
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-I at 14.000
|
—
|
—
|
—
|
0.232 nanogram per milliliter (ng/ml)
Standard Deviation 0.130
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
—
|
—
|
0.360 nanogram per milliliter (ng/ml)
Standard Deviation 0.166
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-I at 14.042
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-I at 21.000
|
—
|
—
|
—
|
0.334 nanogram per milliliter (ng/ml)
Standard Deviation NA
Standard deviation can not be calculated as only one participant evaluated.
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
0.265 nanogram per milliliter (ng/ml)
Standard Deviation 0.189
|
0.241 nanogram per milliliter (ng/ml)
Standard Deviation 0.147
|
0.336 nanogram per milliliter (ng/ml)
Standard Deviation 0.177
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.313 ng/mL).
|
|
Suppression Profiles of IGF-I and IGF-II Post-Administration of MEDI-573
IGF-II at 0.063
|
—
|
—
|
—
|
—
|
—
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL)
|
NA nanogram per milliliter (ng/ml)
Standard Deviation 0.000
Below the limit of quantitation (0.626 ng/mL)
|
—
|
—
|
Adverse Events
MEDI-573 0.5 mg/Kg QWk Dose Escalation
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
MEDI-573 1.5 mg/Kg QWk Dose Escalation
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
Serious events: 4 serious events
Other events: 13 other events
Deaths: 10 deaths
MEDI-573 10 mg/Kg QWk Dose Escalation
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
Serious events: 6 serious events
Other events: 13 other events
Deaths: 9 deaths
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 participants at risk
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 participants at risk
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=14 participants at risk
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 participants at risk
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=13 participants at risk
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 participants at risk
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=3 participants at risk
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
General disorders
Disease progression
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Infections and infestations
Urosepsis
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Blood creatinine increased
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Glomerular filtration rate decreased
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
25.0%
1/4 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
Other adverse events
| Measure |
MEDI-573 0.5 mg/Kg QWk Dose Escalation
n=4 participants at risk
Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 1.5 mg/Kg QWk Dose Escalation
n=3 participants at risk
Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 5 mg/Kg QWk Dose Escalation and Expansion
n=14 participants at risk
Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 10 mg/Kg QWk Dose Escalation
n=3 participants at risk
Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 15 mg/Kg QWk Dose Escalation and Expansion
n=13 participants at risk
Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 30 mg/Kg Q3Wk Dose Escalation
n=3 participants at risk
Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
MEDI-573 45 mg/Kg Q3Wk Dose Escalation
n=3 participants at risk
Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
15.4%
2/13 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 9 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 7 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
14.3%
2/14 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
23.1%
3/13 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
23.1%
3/13 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
14.3%
2/14 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
23.1%
3/13 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
14.3%
2/14 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
46.2%
6/13 • Number of events 7 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Oesophagitis
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
14.3%
2/14 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
General disorders
Asthenia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
General disorders
Chills
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
General disorders
Early satiety
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
General disorders
Fatigue
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
21.4%
3/14 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
61.5%
8/13 • Number of events 10 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
General disorders
Implant site pain
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
General disorders
Local swelling
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
General disorders
Oedema
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
15.4%
2/13 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
General disorders
Thirst
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
25.0%
1/4 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
15.4%
2/13 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Infections and infestations
Candidiasis
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Infections and infestations
Sinusitis
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Infections and infestations
Urinary tract infection
|
50.0%
2/4 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
30.8%
4/13 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
23.1%
3/13 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
14.3%
2/14 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
15.4%
2/13 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
14.3%
2/14 • Number of events 5 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
15.4%
2/13 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
23.1%
3/13 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Blood creatine increased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
14.3%
2/14 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
15.4%
2/13 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Blood growth hormone increased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Blood insulin increased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
25.0%
1/4 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Cardiac enzymes increased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Heart rate increased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Lipase increased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Protein total increased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
Weight increased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
75.0%
3/4 • Number of events 4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
61.5%
8/13 • Number of events 9 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
100.0%
3/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
15.4%
2/13 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
15.4%
2/13 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
14.3%
2/14 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
14.3%
2/14 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Nervous system disorders
Encephalopathy
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Nervous system disorders
Extrapyramidal disorder
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Nervous system disorders
Somnolence
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Psychiatric disorders
Confusional state
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Renal and urinary disorders
Urinary incontinence
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
15.4%
2/13 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
66.7%
2/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
15.4%
2/13 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
14.3%
2/14 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.7%
1/13 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
7.1%
1/14 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
15.4%
2/13 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
14.3%
2/14 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
15.4%
2/13 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
15.4%
2/13 • Number of events 2 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Vascular disorders
Pallor
|
0.00%
0/4 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
33.3%
1/3 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
|
Vascular disorders
Systolic hypertension
|
25.0%
1/4 • Number of events 1 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/14 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/13 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
0.00%
0/3 • From start of study drug administration until 30 days after the last dose of study drug, up to 3.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER