Trial Outcomes & Findings for A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread (NCT NCT03158272)
NCT ID: NCT03158272
Last Updated: 2020-12-21
Results Overview
The number of participants that experienced an AE during the course of the study while participating in cabiralizumab monotherapy treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months
Results posted on
2020-12-21
Participant Flow
19 participants entered the treatment period, and 19 were treated.
Participant milestones
| Measure |
M1 Cohort
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
6
|
6
|
Reasons for withdrawal
| Measure |
M1 Cohort
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Overall Study
Disease progression
|
3
|
3
|
4
|
6
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Other reasons
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse event unrelated to the drug
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Cabiralzumab Given by Itself or With Nivolumab in Advanced Cancer or Cancer That Has Spread
Baseline characteristics by cohort
| Measure |
M1 Cohort
n=3 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=4 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
n=6 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
n=6 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.7 Years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
63.8 Years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
67.0 Years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
64.5 Years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
65.5 Years
STANDARD_DEVIATION 7.1 • n=21 Participants
|
|
Age, Customized
<65
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age, Customized
>=65
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 monthsPopulation: All treated participants participating in carbiralizumab monotherapy
The number of participants that experienced an AE during the course of the study while participating in cabiralizumab monotherapy treatment.
Outcome measures
| Measure |
M1 Cohort
n=3 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=4 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) - Carbiralizumab Monotherapy
|
3 Number of participants
|
4 Number of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 monthsPopulation: All treated participants participating in carbiralizumab monotherapy
The number of participants that experienced a SAE during the course of the study while participating in cabiralizumab monotherapy treatment.
Outcome measures
| Measure |
M1 Cohort
n=3 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=4 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab Monotherapy
|
1 Number of participants
|
2 Number of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days (from first day of treatment)Population: All treated participants participating in carbiralizumab monotherapy
The number of participants that experienced an AE meeting protocol-defined DLT criteria during the course of the study while participating in cabiralizumab monotherapy treatment.
Outcome measures
| Measure |
M1 Cohort
n=3 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=4 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Number of Participants With AEs Meeting Protocol-defined Dose-Limiting Toxicity (DLT) Criteria - Carbiralizumab Monotherapy
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 monthsPopulation: All treated participants participating in carbiralizumab monotherapy
The number of participants that experienced an AE leading to discontinuation during the course of the study while participating in cabiralizumab monotherapy treatment.
Outcome measures
| Measure |
M1 Cohort
n=3 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=4 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Number of Participants With AEs Leading to Discontinuation - Carbiralizumab Monotherapy
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 monthsPopulation: All treated participants participating in carbiralizumab monotherapy
The number of participants that died during the course of the study while participating in cabiralizumab monotherapy treatment.
Outcome measures
| Measure |
M1 Cohort
n=3 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=4 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Number of Participants Who Died - Carbiralizumab Monotherapy
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 monthsPopulation: All treated participants participating in carbiralizumab monotherapy
The number of participants that experienced a laboratory abnormality during the course of the study while participating in cabiralizumab monotherapy treatment.
Outcome measures
| Measure |
M1 Cohort
n=3 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=4 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
HYPERCALCEMIA - grade 0
|
3 Number of participants
|
4 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
HYPERKALEMIA - grade 0
|
2 Number of participants
|
4 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
HYPERKALEMIA - grade 1
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
HYPERNATREMIA - grade 0
|
3 Number of participants
|
4 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
HYPOCALCEMIA - grade 0
|
3 Number of participants
|
2 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
HYPOCALCEMIA - grade 1
|
0 Number of participants
|
2 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
HYPOKALEMIA - grade 0
|
3 Number of participants
|
3 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
HYPOKALEMIA -grade 1
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
HYPONATREMIA - grade 0
|
1 Number of participants
|
4 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
HYPONATREMIA - grade 1
|
2 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
HEMOGLOBIN - grade 1
|
2 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
HEMOGLOBIN - grade 2
|
1 Number of participants
|
4 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
PLATELET COUNT - grade 0
|
3 Number of participants
|
4 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
LEUKOCYTES - grade 0
|
3 Number of participants
|
3 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
LEUKOCYTES - grade 2
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
ABSOLUTE NEUTROPHIL COUNT - grade 0
|
3 Number of participants
|
3 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
ABSOLUTE NEUTROPHIL COUNT - grade 2
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
LYMPHOCYTES (ABSOLUTE) - grade 0
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
LYMPHOCYTES (ABSOLUTE) - grade 2
|
2 Number of participants
|
3 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
LYMPHOCYTES (ABSOLUTE) - grade 3
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
NEUTROPHILS (ABSOLUTE) - grade 0
|
2 Number of participants
|
3 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
NEUTROPHILS (ABSOLUTE) - grade 1
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
NEUTROPHILS (ABSOLUTE) - grade 2
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
CREATININE - grade 0
|
2 Number of participants
|
3 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
CREATININE - grade 1
|
1 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
ALKALINE PHOSPHATASE (ALP) - grade 0
|
0 Number of participants
|
3 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
ALKALINE PHOSPHATASE (ALP) - grade 1
|
2 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
ALKALINE PHOSPHATASE (ALP) - grade 2
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
ALANINE AMINOTRANSFERASE (ALT) - grade 0
|
3 Number of participants
|
2 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
ALANINE AMINOTRANSFERASE (ALT) - grade 1
|
0 Number of participants
|
2 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
ASPARTATE AMINOTRANSFERASE (AST) - grade 0
|
1 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
ASPARTATE AMINOTRANSFERASE (AST) - grade 1
|
2 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
ASPARTATE AMINOTRANSFERASE (AST) - grade 2
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
ASPARTATE AMINOTRANSFERASE (AST) - grade 3
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy
BILIRUBIN, TOTAL - grade 0
|
3 Number of participants
|
4 Number of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 monthsPopulation: All treated participants participating in carbiralizumab and nivolumab combo therapy
The number of participants that experienced an AE during the course of the study while participating in cabiralizumab and nivolumab combination therapy.
Outcome measures
| Measure |
M1 Cohort
n=6 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=6 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) - Carbiralizumab and Nivolumab Combo Therapy
|
6 Number of participants
|
5 Number of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 monthsPopulation: All treated participants participating in carbiralizumab and nivolumab combo therapy
The number of participants that experienced an SAE during the course of the study while participating in cabiralizumab and nivolumab combination therapy.
Outcome measures
| Measure |
M1 Cohort
n=6 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=6 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab and Nivolumab Combo Therapy
|
1 Number of participants
|
1 Number of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 monthsPopulation: All treated participants participating in carbiralizumab and nivolumab combo therapy
The number of participants that experienced an AE leading to discontinuation during the course of the study while participating in cabiralizumab and nivolumab combination therapy.
Outcome measures
| Measure |
M1 Cohort
n=6 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=6 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Number of Participants With AEs Leading to Discontinuation - Carbiralizumab and Nivolumab Combo Therapy
|
1 Number of participants
|
1 Number of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 monthsPopulation: All treated participants participating in carbiralizumab and nivolumab combo therapy
The number of participants that died during the course of the study while participating in cabiralizumab and nivolumab combination therapy.
Outcome measures
| Measure |
M1 Cohort
n=6 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=6 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Number of Participants Who Died - Carbiralizumab and Nivolumab Combo Therapy
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 monthsPopulation: All treated participants participating in carbiralizumab and nivolumab combo therapy
The number of participants that experienced a laboratory abnormality during the course of the study while participating in carbiralizumab and nivolumab combination therapy
Outcome measures
| Measure |
M1 Cohort
n=6 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=6 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
ABSOLUTE NEUTROPHIL COUNT - grade 4
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
LYMPHOCYTES (ABSOLUTE) - grade 1
|
3 Number of participants
|
3 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
LYMPHOCYTES (ABSOLUTE) - grade 2
|
2 Number of participants
|
2 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
LYMPHOCYTES (ABSOLUTE) - grade 3
|
1 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
NEUTROPHILS (ABSOLUTE) - grade 0
|
3 Number of participants
|
3 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
NEUTROPHILS (ABSOLUTE) - grade 1
|
2 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
NEUTROPHILS (ABSOLUTE) - grade 2
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
NEUTROPHILS (ABSOLUTE) - grade 3
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
NEUTROPHILS (ABSOLUTE) - grade 4
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
CREATININE - grade 0
|
3 Number of participants
|
4 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
CREATININE - grade 1
|
2 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
CREATININE - grade 2
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
CREATININE - grade 3
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
ALKALINE PHOSPHATASE (ALP) - grade 0
|
1 Number of participants
|
4 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
ALKALINE PHOSPHATASE (ALP) - grade 1
|
3 Number of participants
|
2 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
ALKALINE PHOSPHATASE (ALP) - grade 2
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
ALKALINE PHOSPHATASE (ALP) - grade 3
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
ALANINE AMINOTRANSFERASE (ALT) - grade 0
|
2 Number of participants
|
4 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
ALANINE AMINOTRANSFERASE (ALT) - grade 1
|
4 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
ALANINE AMINOTRANSFERASE (ALT) - grade 2
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
ASPARTATE AMINOTRANSFERASE (AST) - grade 1
|
1 Number of participants
|
4 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
ASPARTATE AMINOTRANSFERASE (AST) - grade 2
|
2 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
ASPARTATE AMINOTRANSFERASE (AST) - grade 3
|
3 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
BILIRUBIN, TOTAL - grade 0
|
5 Number of participants
|
6 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
BILIRUBIN, TOTAL - grade 2
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HYPERCALCEMIA - grade 0
|
6 Number of participants
|
6 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HYPERKALEMIA - grade 0
|
3 Number of participants
|
5 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HYPERKALEMIA - grade 1
|
3 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HYPERNATREMIA - grade 0
|
6 Number of participants
|
5 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HYPERNATREMIA - grade 1
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HYPOCALCEMIA - grade 0
|
1 Number of participants
|
2 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HYPOCALCEMIA - grade 1
|
4 Number of participants
|
3 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HYPOCALCEMIA - grade 2
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HYPOCALCEMIA - grade 3
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HYPOKALEMIA - grade 0
|
5 Number of participants
|
3 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HYPOKALEMIA -grade 1
|
0 Number of participants
|
2 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HYPOKALEMIA - grade 3
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HYPONATREMIA - grade 0
|
3 Number of participants
|
5 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HYPONATREMIA - grade 1
|
3 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HEMOGLOBIN - grade 1
|
3 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HEMOGLOBIN - grade 2
|
3 Number of participants
|
4 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
HEMOGLOBIN - grade 3
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
PLATELET COUNT - grade 0
|
4 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
PLATELET COUNT - grade 1
|
1 Number of participants
|
3 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
PLATELET COUNT - grade 2
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
PLATELET COUNT - grade 3
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
PLATELET COUNT - grade 4
|
0 Number of participants
|
2 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
LEUKOCYTES - grade 0
|
3 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
LEUKOCYTES - grade 1
|
2 Number of participants
|
2 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
LEUKOCYTES - grade 2
|
1 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
LEUKOCYTES - grade 3
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
LEUKOCYTES - grade 4
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
ABSOLUTE NEUTROPHIL COUNT - grade 0
|
3 Number of participants
|
3 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
ABSOLUTE NEUTROPHIL COUNT - grade 1
|
2 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
ABSOLUTE NEUTROPHIL COUNT - grade 2
|
1 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy
ABSOLUTE NEUTROPHIL COUNT - grade 3
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 (pre-dose), Cycle 8 (pre-dose)Population: All treated participants who completed through cycle 8 visit
Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. Ctrough Accumulation Index; ratio of Ctrough at steady-state (i.e. Cycle 8) to Ctrough after the first dose Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. AI = Ctrough on cycle 8 / Ctrough on Cycle 2
Outcome measures
| Measure |
M1 Cohort
n=2 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
n=2 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
AI_Ctrough
|
NA Ratio of Ctrough: cycle 8 to cycle 2
Geometric Coefficient of Variation NA
Data not reported due to privacy reasons
|
—
|
NA Ratio of Ctrough: cycle 8 to cycle 2
Geometric Coefficient of Variation NA
Data not reported due to privacy reasons
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)Population: All treated participants
Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. AUC(0-T) is defined as the area under the serum concentration-time curve from time zero to time of last quantifiable concentration after the first dose. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.
Outcome measures
| Measure |
M1 Cohort
n=3 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=4 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
n=6 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
n=6 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
AUC(0-T)
|
4992 h*µg/mL
Geometric Coefficient of Variation 16
|
11668 h*µg/mL
Geometric Coefficient of Variation 14
|
9969 h*µg/mL
Geometric Coefficient of Variation 30
|
8723 h*µg/mL
Geometric Coefficient of Variation 26
|
SECONDARY outcome
Timeframe: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)Population: All treated participants
Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. AUC(TAU) is defined as the area under the serum concentration-time curve in one dosing interval. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.
Outcome measures
| Measure |
M1 Cohort
n=3 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=4 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
n=6 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
n=6 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
AUC(TAU)
|
4992 h*µg/mL
Geometric Coefficient of Variation 16
|
12499 h*µg/mL
Geometric Coefficient of Variation 2
|
9969 h*µg/mL
Geometric Coefficient of Variation 30
|
10590 h*µg/mL
Geometric Coefficient of Variation 6
|
SECONDARY outcome
Timeframe: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)Population: All treated participants
Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. Cmax is defined as the maximum observed serum concentration. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.
Outcome measures
| Measure |
M1 Cohort
n=3 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=4 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
n=6 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
n=6 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Cmax
|
43.7 µg/mL
Geometric Coefficient of Variation 20
|
91.4 µg/mL
Geometric Coefficient of Variation 7
|
84.8 µg/mL
Geometric Coefficient of Variation 19
|
76.2 µg/mL
Geometric Coefficient of Variation 15
|
SECONDARY outcome
Timeframe: Cycles 1, 2, 3, 4, 5, 6, 7, 8, 9Population: All treated participants for all cohorts for Cabiralizumab; All treated participants for Cohorts C1 and C2 for Nivolumab. Note: Data reported for the cycles that were reached.
Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. Ctrough is defined as the Trough observed serum concentration (predose at each cycle). Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.
Outcome measures
| Measure |
M1 Cohort
n=3 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=4 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
n=6 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
n=3 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Ctrough
Cabiralizumab cycle 9
|
0.304 µg/mL
Geometric Coefficient of Variation NA
only 1 participant reached this cycle, CV not evaluable
|
—
|
30.5 µg/mL
Geometric Coefficient of Variation NA
only 1 participant reached this cycle, CV not evaluable
|
—
|
|
Ctrough
Nivolumab cycle 2
|
—
|
—
|
16.4 µg/mL
Geometric Coefficient of Variation 12
|
17.5 µg/mL
Geometric Coefficient of Variation 8
|
|
Ctrough
Nivolumab cycle 3
|
—
|
—
|
25.8 µg/mL
Geometric Coefficient of Variation 14
|
—
|
|
Ctrough
Nivolumab cycle 5
|
—
|
—
|
42.1 µg/mL
Geometric Coefficient of Variation NA
only 1 participant reached this cycle, CV not evaluable
|
—
|
|
Ctrough
Nivolumab cycle 9
|
—
|
—
|
49.2 µg/mL
Geometric Coefficient of Variation NA
only 1 participant reached this cycle, CV not evaluable
|
—
|
|
Ctrough
Cabiralizumab cycle 2
|
2.44 µg/mL
Geometric Coefficient of Variation 105
|
18.5 µg/mL
Geometric Coefficient of Variation 1
|
10.1 µg/mL
Geometric Coefficient of Variation 50
|
16.5 µg/mL
Geometric Coefficient of Variation 14
|
|
Ctrough
Cabiralizumab cycle 3
|
4.70 µg/mL
Geometric Coefficient of Variation 95
|
39.8 µg/mL
Geometric Coefficient of Variation 25
|
18.8 µg/mL
Geometric Coefficient of Variation 53
|
—
|
|
Ctrough
Cabiralizumab cycle 4
|
2.27 µg/mL
Geometric Coefficient of Variation 46
|
45.8 µg/mL
Geometric Coefficient of Variation 20
|
24.5 µg/mL
Geometric Coefficient of Variation 48
|
—
|
|
Ctrough
Cabiralizumab cycle 5
|
1.43 µg/mL
Geometric Coefficient of Variation 64
|
—
|
53.3 µg/mL
Geometric Coefficient of Variation NA
only 1 participant reached this cycle, CV not evaluable
|
—
|
|
Ctrough
Cabiralizumab cycle 6
|
1.49 µg/mL
Geometric Coefficient of Variation 88
|
—
|
55.8 µg/mL
Geometric Coefficient of Variation NA
only 1 participant reached this cycle, CV not evaluable
|
—
|
|
Ctrough
Cabiralizumab cycle 7
|
1.52 µg/mL
Geometric Coefficient of Variation 108
|
—
|
14.0 µg/mL
Geometric Coefficient of Variation 110
|
—
|
|
Ctrough
Cabiralizumab cycle 8
|
1.53 µg/mL
Geometric Coefficient of Variation 124
|
—
|
37.7 µg/mL
Geometric Coefficient of Variation 29
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 (pre-dose), Cycle 8 (pre-dose)Population: All treated participants who completed through cycle 8 visit
Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. T-HALFeff\_Ctrough is defined as the effective elimination half-life that explains the degree of Ctrough accumulation observed. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.
Outcome measures
| Measure |
M1 Cohort
n=1 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
n=2 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
T-HALFeff_Ctrough
|
NA hour
Data not reported due to privacy reasons
|
—
|
NA hour
Data not reported due to privacy reasons
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour)Population: All treated participants
Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. Tmax is defined as the time of maximum observed serum concentration. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.
Outcome measures
| Measure |
M1 Cohort
n=3 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=4 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
n=6 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
n=6 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Tmax
|
3.18 h (Hour)
Interval 0.533 to 4.62
|
0.546 h (Hour)
Interval 0.5 to 0.633
|
1.14 h (Hour)
Interval 0.517 to 4.0
|
1.32 h (Hour)
Interval 0.55 to 4.25
|
SECONDARY outcome
Timeframe: Day 1 pre-dose for cycles 2, 3, 5, 9, 13, 21Population: All treated participants
To characterize the immunogenicity of cabiralizumab and nivolumab. Baseline ADA-positive participant is defined as a participant who has a ADA detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy.
Outcome measures
| Measure |
M1 Cohort
n=3 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=4 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
n=6 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
n=6 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Incidence of Anti-drug Antibodies (ADA)
Cabiralizumab data
|
1 Number of participants
|
0 Number of participants
|
2 Number of participants
|
0 Number of participants
|
|
Incidence of Anti-drug Antibodies (ADA)
Nivolumab data
|
NA Number of participants
No data collected for nivolumab; cohort is cabiralizumab monotherapy only
|
NA Number of participants
No data collected for nivolumab; cohort is cabiralizumab monotherapy only
|
1 Number of participants
|
0 Number of participants
|
SECONDARY outcome
Timeframe: From first dose to end of follow-up, assessed up to July 2019, approximately 24 monthsPopulation: All treated participants
To assess the preliminary anti-tumor activity of cabiralizumab administered alone and in combination with nivolumab per RECIST 1.1 (M1, M2, C1 cohorts: participants with advanced solid tumors) and per IMWG criteria (Cohort C2: participants with hematologic malignancies). IMWG: International Myeloma Working Group RECIST: Response Evaluation Criteria in Solid Tumors
Outcome measures
| Measure |
M1 Cohort
n=3 Participants
2 mg/kg cabiralizumab monotherapy
|
M2 Cohort
n=4 Participants
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
n=6 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
n=6 Participants
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Best Overall Response (BOR)
Stable disease
|
2 Number of participants
|
0 Number of participants
|
3 Number of participants
|
0 Number of participants
|
|
Best Overall Response (BOR)
Progression
|
1 Number of participants
|
3 Number of participants
|
3 Number of participants
|
6 Number of participants
|
|
Best Overall Response (BOR)
Not evaluable
|
0 Number of participants
|
1 Number of participants
|
3 Number of participants
|
0 Number of participants
|
SECONDARY outcome
Timeframe: From first dose to end of follow-upPopulation: All treated participants Note: there is no DOR data to report as no participant had a BOR of CR or PR or better.
To assess the preliminary anti-tumor activity of cabiralizumab administered alone and in combination with nivolumab per RECIST 1.1 (M1, M2, C1 cohorts: participants with advanced solid tumors) and per IMWG criteria (Cohort C2: participants with hematologic malignancies). IMWG: International Myeloma Working Group RECIST: Response Evaluation Criteria in Solid Tumors Duration of response (DOR) was listed for participants with a BOR of complete response (CR) or partial response (PR).
Outcome measures
Outcome data not reported
Adverse Events
M1 Cohort
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
M2 Cohort
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
C1 Cohort
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
C2 Cohort
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
M1 Cohort
n=3 participants at risk
2 mg/kg cabiralizumab monotherap
|
M2 Cohort
n=4 participants at risk
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
n=6 participants at risk
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
n=6 participants at risk
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Gastrointestinal disorders
Anorectal disorder
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Infections and infestations
Cholangitis infective
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Infections and infestations
Gastritis bacterial
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Infections and infestations
Liver abscess
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Renal and urinary disorders
Bladder disorder
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
Other adverse events
| Measure |
M1 Cohort
n=3 participants at risk
2 mg/kg cabiralizumab monotherap
|
M2 Cohort
n=4 participants at risk
4 mg/kg cabiralizumab monotherapy
|
C1 Cohort
n=6 participants at risk
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor
|
C2 Cohort
n=6 participants at risk
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
66.7%
4/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Eye disorders
Periorbital oedema
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
33.3%
2/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
33.3%
2/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
33.3%
2/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
General disorders
Face oedema
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
General disorders
Fatigue
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
General disorders
Pyrexia
|
66.7%
2/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Investigations
Amylase increased
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
50.0%
2/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
66.7%
4/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
50.0%
3/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
75.0%
3/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
100.0%
6/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
50.0%
3/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
66.7%
4/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Investigations
Blood creatine phosphokinase increased
|
66.7%
2/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
75.0%
3/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
100.0%
6/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
66.7%
4/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
50.0%
3/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Investigations
Lipase increased
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
50.0%
2/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
66.7%
4/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
33.3%
2/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
33.3%
2/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
50.0%
3/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
16.7%
1/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
25.0%
1/4 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
0.00%
0/6 • From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60