Trial Outcomes & Findings for An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer (NCT NCT04089553)
NCT ID: NCT04089553
Last Updated: 2024-04-16
Results Overview
The confirmed objective response is defined as confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1 guidelines, assessed by computed tomography (CT) scan/ magnetic resonance imaging (MRI) scan/ positron emission tomography (PET) scan and bone scan. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
Baseline (Day -28) through end of study (last participant last visit) (approximately 22 months)
Results posted on
2024-04-16
Participant Flow
Participant milestones
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
26
|
28
|
Reasons for withdrawal
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Progressive disease - objective (AZD4635)
|
13
|
20
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Progressive disease - subjective (AZD4635)
|
6
|
3
|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
Baseline Characteristics
An Open-label, Phase II Study of AZD4635 in Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=29 Participants
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
n=30 Participants
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.2 Years
STANDARD_DEVIATION 7.10 • n=5 Participants
|
72.7 Years
STANDARD_DEVIATION 7.33 • n=7 Participants
|
72.5 Years
STANDARD_DEVIATION 7.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -28) through end of study (last participant last visit) (approximately 22 months)Population: Tumor response analysis set included all participants who received at least one dose of study drug and had a baseline tumor assessment and measurable disease at baseline.
The confirmed objective response is defined as confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1 guidelines, assessed by computed tomography (CT) scan/ magnetic resonance imaging (MRI) scan/ positron emission tomography (PET) scan and bone scan. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression in-between.
Outcome measures
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=20 Participants
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
n=21 Participants
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With Confirmed Objective Response Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
|
5 Percentage of participants
Interval 0.1 to 24.9
|
0 Percentage of participants
Interval to 16.1
Lower limit of 95% CI was not reached because an insufficient number of participants had objective response.
|
PRIMARY outcome
Timeframe: Baseline (Day -28) through end of study (last participant last visit) (approximately 22 months)Population: The PSA response analysis set included all participants who received at least one dose of study drug and had an abnormal baseline PSA data (\>= 1 ng/mL).
A confirmed PSA response is defined as reduction in the PSA level of \>= 50% from baseline to the lowest post-baseline PSA results, measured twice, at least 3 weeks apart by the PCWG3 criteria.
Outcome measures
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=28 Participants
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
n=30 Participants
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With Confirmed Prostate-specific Antigen (PSA) Response Per Prostate Cancer Working Group 3 (PCWG3) Criteria
|
3.6 Percentage of participants
Interval 0.1 to 18.3
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
SECONDARY outcome
Timeframe: Baseline (Day -28) through end of study (last participant last visit) (approximately 22 months)Population: Efficacy analysis set included all participants who received at least one dose of study drug and had a baseline tumor assessment.
The rPFS is defined as the time interval from the first dose of AZD4635 until the date of radiological disease progression (RECIST 1.1 for soft tissue lesions and PCWG3 criteria for bone lesions) or death (by any cause in the absence of progression) regardless of whether the participant withdrew from study therapy or received another anti-cancer therapy prior to progression. The progressive disease for soft lesions per RECIST 1.1 (assessed by CT/MRI/PET scan) is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum in the study, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. The progressive disease for bone lesions per PCWG3 is defined as at least 2 or more new metastatic bone lesions observed compared to baseline assessment (Day -28), with confirmation scan performed at least 6-week later.
Outcome measures
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=29 Participants
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
n=30 Participants
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Percentage of Participants With Radiological Progression Free Survival (rPFS) at 6 Months
|
8.8 Percentage of participants
Interval 0.71 to 30.28
|
11.1 Percentage of participants
Interval 2.83 to 25.75
|
SECONDARY outcome
Timeframe: Baseline (Day -28) through end of study (last participant last visit) (approximately 22 months)Population: Tumor response analysis set included all participants who received at least one dose of study drug and had a baseline tumor assessment (Day -28) and measurable disease at baseline. Participants who had confirmed CR/PR were analyzed for this outcome measure.
The DoR is defined as the time from the date of first documented response (confirmed CR/PR) until date of documented progression or death in the absence of disease progression. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as \>= 30% decrease in the sum of the diameters of target lesions compared to baseline and no new non-target lesion. A confirmed CR or PR is defined as 2 CRs or 2 PRs that were separated by at least 4 weeks with no evidence of progression or not evaluable response in-between. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. The DoR was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=1 Participants
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Duration of Response (DoR)
|
NA Months
Median and inter-quartile range could not be determined because insufficient number of participants were evaluated for the specified arm.
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -28) through end of study (last participant last visit) (approximately 22 months)Population: Safety analysis set included all participants who received at least one dose of study drug.
The OS is defined as the time from date of first study dose until the date of death due to any cause. The median of OS was estimated using Kaplan-Meier method and CI was derived based on Brookmeyer-Crowley method.
Outcome measures
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=29 Participants
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
n=30 Participants
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Overall Survival (OS)
|
10.72 Months
Interval 7.2 to
Upper limit of 95% CI was not determined because an insufficient number of participants had events.
|
NA Months
Interval 10.65 to
Median and upper limit of 95% CI were not determined because an insufficient number of participants had events.
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, 2, 4, and 7 and 90 days following the last dose of durvalumab (approximately 22 months)Population: Safety analysis set included all participants who received at least one dose of durvalumab and had at least one post dose ADA sample.
The detection of the immunogenicity of monoclonal antibody to durvalumab was performed using a validated immunoassay method. Participants with positive ADA to durvalumab are reported.
Outcome measures
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=26 Participants
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA) to Durvalumab
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, 3, 5, and every 12 weeks thereafter, and 90 days following the last dose of oleclumab (approximately 22 months)Population: Safety analysis set included all participants who received at least one dose of oleclumab and had at least one post dose ADA sample.
The detection of the immunogenicity of monoclonal antibody to oleclumab was performed using a validated immunoassay method. Participants with positive ADA to oleclumab are reported.
Outcome measures
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=24 Participants
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Number of Participants With Positive ADA to Oleclumab
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Predose on Day 1 of Cycle 7Population: Pharmacokinetics (PK) analysis set included all participants who received at least one dose of AZD4635 and had at least 1 reportable PK concentration at Cycle 7.
Plasma concentrations of AZD4635 and its metabolites (SSP-005173 and SSP-005174) are reported.
Outcome measures
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=3 Participants
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
n=3 Participants
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Plasma Concentrations of AZD4635 and Its Metabolites (SSP-005173 and SSP-005174)
AZD4635 concentration
|
97.64 ng/mL
Geometric Coefficient of Variation 21.67
|
75.47 ng/mL
Geometric Coefficient of Variation 83.37
|
|
Plasma Concentrations of AZD4635 and Its Metabolites (SSP-005173 and SSP-005174)
SSP-005173 concentration
|
5.386 ng/mL
Geometric Coefficient of Variation 95.48
|
6.905 ng/mL
Geometric Coefficient of Variation 160.2
|
|
Plasma Concentrations of AZD4635 and Its Metabolites (SSP-005173 and SSP-005174)
SSP-005174 concentration
|
13.24 ng/mL
Geometric Coefficient of Variation 69.59
|
11.79 ng/mL
Geometric Coefficient of Variation 75.23
|
SECONDARY outcome
Timeframe: Predose and end of infusion on Day 1 of Cycle 7Population: The PK analysis set included all participants who received at least one dose of durvalumab and had at least 1 reportable PK concentration at Cycle 7. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Plasma concentration of durvalumab is reported.
Outcome measures
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=2 Participants
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Plasma Concentration of Durvalumab
Pre-dose
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variation were not reported as an insufficient participants were evaluated for the specified time point.
|
—
|
|
Plasma Concentration of Durvalumab
End of infusion
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variation were not reported as only one participant was evaluated for the specified time point.
|
—
|
SECONDARY outcome
Timeframe: Predose and 10 minutes end of infusion on Day 1 of Cycle 14Population: The PK analysis set included all participants who received at least one dose of oleclumab and had at least 1 reportable PK concentration at Cycle 7. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Plasma concentration of oleclumab is reported.
Outcome measures
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=1 Participants
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Plasma Concentration of Oleclumab
Pre-dose
|
NA mcg/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variation were not reported as only one participant was evaluated for the specified time point.
|
—
|
|
Plasma Concentration of Oleclumab
10 minutes end of infusion
|
NA mcg/mL
Geometric Coefficient of Variation NA
Geometric mean and geometric coefficient of variation were not reported as only one participant was evaluated for the specified time point.
|
—
|
SECONDARY outcome
Timeframe: Day 1 through 90 days after the last dose of study drug (approximately 22 months)Population: Safety analysis set included all participants who received at least one dose of study drug.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Outcome measures
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=29 Participants
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
n=30 Participants
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Any TEAEs
|
27 Participants
|
29 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Any TESAEs
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) through 90 days after the last dose of study drug (approximately 22 months)Population: Safety analysis set included all participants who received at least one dose of study drug.
Laboratory parameters included hematology, coagulation, clinical chemistry, and urinalysis. The CTCAE is a descriptive terminology is used for AE reporting. The CTCAE v5.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death related to AE. Participants with CTCAE v5.0 grade change in laboratory parameters from baseline (Day 1 before the start of study treatment) to Grade 3 or more are reported.
Outcome measures
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=29 Participants
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
n=30 Participants
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Number of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade Change in Laboratory Parameters From Baseline to Grade 3 or More
Hemoglobin (low)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade Change in Laboratory Parameters From Baseline to Grade 3 or More
Leukocytes (low)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade Change in Laboratory Parameters From Baseline to Grade 3 or More
Lymphocytes (low)
|
4 Participants
|
6 Participants
|
|
Number of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade Change in Laboratory Parameters From Baseline to Grade 3 or More
Albumin
|
1 Participants
|
0 Participants
|
|
Number of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade Change in Laboratory Parameters From Baseline to Grade 3 or More
Alkaline Phosphatase
|
1 Participants
|
0 Participants
|
|
Number of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade Change in Laboratory Parameters From Baseline to Grade 3 or More
Gamma Glutamyl Transferase
|
1 Participants
|
0 Participants
|
|
Number of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade Change in Laboratory Parameters From Baseline to Grade 3 or More
Lipase
|
3 Participants
|
1 Participants
|
|
Number of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade Change in Laboratory Parameters From Baseline to Grade 3 or More
Sodium (low)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 through 90 days after the last dose of study drug (approximately 22 months)Population: Safety analysis set included all participants who received at least one dose of study drug.
Vital signs assessment included body temperature, respiration rate, pulse rate, blood pressure, and weight. Participants with abnormal vital signs and/or abnormal physical examination reported as TEAEs are reported.
Outcome measures
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=29 Participants
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
n=30 Participants
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs
Cachexia
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs
Hypertension
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs
Hypotension
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs
Gait disturbance
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs
Pyrexia
|
0 Participants
|
2 Participants
|
Adverse Events
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
Serious events: 6 serious events
Other events: 27 other events
Deaths: 12 deaths
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
Serious events: 8 serious events
Other events: 28 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=29 participants at risk
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
n=30 participants at risk
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
3.4%
1/29 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Renal and urinary disorders
Haematuria
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Infections and infestations
Covid-19
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Infections and infestations
Urinary tract infection
|
6.9%
2/29 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
1/29 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
Other adverse events
| Measure |
Module 1 (AZD4635 75 mg + Durvalumab 1500 mg)
n=29 participants at risk
Participants received monotherapy of AZD4635 75 mg orally once daily (QD) for first 14 days and thereafter continued to receive 75 mg orally QD in combination with durvalumab 1500 mg intravenously (IV) every 4 weeks (Q4W) until derived clinical benefit as judged by the investigator, confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
Module 2 (AZD4635 50 / 75 mg + Oleclumab 1500 mg)
n=30 participants at risk
Participants received combination therapy of AZD4635 (50 mg / 75 mg orally QD) and oleclumab 1500 mg IV (every 2 weeks of 28-day cycle for the first 4 doses and Q4W thereafter) until derived clinical benefit as judged by the investigator or until confirmed disease progression, unacceptable toxicity, started alternative anticancer therapy, withdrawal of consent, or lost to-follow-up, whichever occurred first.
|
|---|---|---|
|
Eye disorders
Eye pain
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Psychiatric disorders
Agitation
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Psychiatric disorders
Confusional state
|
6.9%
2/29 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Psychiatric disorders
Depression
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Psychiatric disorders
Hallucination
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Psychiatric disorders
Insomnia
|
10.3%
3/29 • Number of events 3 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.4%
1/29 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
10.0%
3/30 • Number of events 4 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Reproductive system and breast disorders
Prostatic pain
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
13.3%
4/30 • Number of events 4 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
10.0%
3/30 • Number of events 3 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 3 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.9%
2/29 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Vascular disorders
Embolism
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Vascular disorders
Flushing
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Vascular disorders
Hot flush
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Vascular disorders
Hypertension
|
3.4%
1/29 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Vascular disorders
Hypotension
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Vascular disorders
Thrombosis
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
3/29 • Number of events 3 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
13.3%
4/30 • Number of events 4 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Constipation
|
13.8%
4/29 • Number of events 4 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
13.3%
4/30 • Number of events 5 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
13.8%
4/29 • Number of events 4 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
16.7%
5/30 • Number of events 5 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
10.3%
3/29 • Number of events 3 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
10.0%
3/30 • Number of events 3 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Nausea
|
44.8%
13/29 • Number of events 14 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
53.3%
16/30 • Number of events 19 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Gastrointestinal disorders
Vomiting
|
13.8%
4/29 • Number of events 9 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
23.3%
7/30 • Number of events 8 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
General disorders
Asthenia
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
General disorders
Chills
|
6.9%
2/29 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
13.3%
4/30 • Number of events 4 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
General disorders
Fatigue
|
24.1%
7/29 • Number of events 7 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
43.3%
13/30 • Number of events 13 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
General disorders
Gait disturbance
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
General disorders
Infusion site extravasation
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
General disorders
Localised oedema
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
General disorders
Non-cardiac chest pain
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
General disorders
Oedema peripheral
|
10.3%
3/29 • Number of events 3 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
General disorders
Pain
|
6.9%
2/29 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
General disorders
Pyrexia
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 3 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Infections and infestations
Cystitis
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Infections and infestations
Gingivitis
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Infections and infestations
Rash pustular
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Infections and infestations
Skin infection
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Infections and infestations
Tooth infection
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Infections and infestations
Urinary tract infection
|
13.8%
4/29 • Number of events 5 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 6 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Investigations
Amylase increased
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Investigations
Aspartate aminotransferase increased
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
10.3%
3/29 • Number of events 3 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Investigations
Blood creatinine increased
|
17.2%
5/29 • Number of events 5 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Investigations
International normalised ratio increased
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Investigations
Lipase increased
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Investigations
Urine output decreased
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Investigations
Weight decreased
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Metabolism and nutrition disorders
Cachexia
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.7%
6/29 • Number of events 6 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
26.7%
8/30 • Number of events 8 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
13.3%
4/30 • Number of events 5 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Metabolism and nutrition disorders
Vitamin b12 deficiency
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 3 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Cardiac disorders
Sinus tachycardia
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
3/29 • Number of events 3 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
13.3%
4/30 • Number of events 4 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.9%
2/29 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.3%
3/29 • Number of events 3 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Nervous system disorders
Dizziness
|
13.8%
4/29 • Number of events 4 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
6.7%
2/30 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Nervous system disorders
Hypoaesthesia
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.9%
2/29 • Number of events 2 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Nervous system disorders
Spinal cord compression
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Nervous system disorders
Transient ischaemic attack
|
3.4%
1/29 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
0.00%
0/30 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
|
Nervous system disorders
Tremor
|
0.00%
0/29 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
3.3%
1/30 • Number of events 1 • Day 1 through 90 days after the last dose of study drug (approximately 22 months)
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER