Trial Outcomes & Findings for AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL (NCT NCT05140382)
NCT ID: NCT05140382
Last Updated: 2024-08-28
Results Overview
Objective response rate is defined as the proportion of participants who have a tumour response of complete response \[CR\] or partial response \[PR\] according to the Lugano (2014) response criteria for malignant lymphoma.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months)
Results posted on
2024-08-28
Participant Flow
The study was conducted from 15 December 2021 and completed on 16 February 2024. The study was conducted at 27 sites in 7 countries worldwide (Australia, France, Italy, South Korea, Taiwan, United Kingdom and United States).
Participants who met the inclusion criteria and none of the exclusion criteria were enrolled to the study. All study assessments were performed as per the schedule of assessment.
Participant milestones
| Measure |
Cohort 1 Non-natural Killer Peripheral T-cell Lymphoma (Non NK PTCL)
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 Natural Killer T-cell Lymphoma (NK PTCL)
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 Classical Hodgkins Lymphoma (cHL)
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
2
|
19
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
31
|
2
|
19
|
Reasons for withdrawal
| Measure |
Cohort 1 Non-natural Killer Peripheral T-cell Lymphoma (Non NK PTCL)
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 Natural Killer T-cell Lymphoma (NK PTCL)
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 Classical Hodgkins Lymphoma (cHL)
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Overall Study
Death
|
3
|
0
|
0
|
|
Overall Study
Investigator decision
|
1
|
0
|
0
|
|
Overall Study
Other
|
4
|
0
|
1
|
|
Overall Study
Progressive disease
|
20
|
1
|
12
|
|
Overall Study
Subjective disease progression
|
2
|
1
|
0
|
|
Overall Study
Unknown at data cut-off
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
4
|
|
Overall Study
Withdrawal of consent
|
0
|
0
|
1
|
Baseline Characteristics
AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL
Baseline characteristics by cohort
| Measure |
Cohort 1 Non-NK PTCL
n=31 Participants
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=2 Participants
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=19 Participants
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.1 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
61.0 Years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
46.5 Years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
55.2 Years
STANDARD_DEVIATION 14.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
18 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Not reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Missing
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Missing
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months)Population: Response evaluable set included all dosed participants who had measurable disease at baseline.
Objective response rate is defined as the proportion of participants who have a tumour response of complete response \[CR\] or partial response \[PR\] according to the Lugano (2014) response criteria for malignant lymphoma.
Outcome measures
| Measure |
Cohort 1 Non-NK PTCL
n=31 Participants
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=2 Participants
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=19 Participants
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
22.6 Percentage of participants
Interval 9.59 to 41.1
|
0 Percentage of participants
Interval 0.0 to 84.19
|
21.1 Percentage of participants
Interval 6.05 to 45.57
|
SECONDARY outcome
Timeframe: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).Population: Response evaluable set included all dosed participants who had measurable disease at baseline.
Complete response rate is defined as proportion of participants who have a complete response according to the Lugano (2014) response criteria.
Outcome measures
| Measure |
Cohort 1 Non-NK PTCL
n=31 Participants
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=2 Participants
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=19 Participants
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Complete Response (CR) Rate
|
19.4 Percentage of participants
|
0 Percentage of participants
|
15.8 Percentage of participants
|
SECONDARY outcome
Timeframe: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).Population: Response evaluable set included all dosed participants who have measurable disease at baseline and had objective response.
Duration of response is defined as the time from the first objective response to the time of documented disease progression or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Cohort 1 Non-NK PTCL
n=7 Participants
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=4 Participants
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Duration of Response (DoR)
|
NA Months
Interval 1.8 to
The median and 95% CI were calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and were non estimable as there was insufficient number of participants with the event of interest (less than 50%) occurred in the study.
|
—
|
5.2 Months
Interval 1.9 to
The 95% CI was calculated with the Kaplan Meier process (a process in medical research to measure the proportion of participants surviving for a certain time after receiving treatment) and was non estimable as there was insufficient number of participants with the event of interest (less than 50%) occurred in the study.
|
SECONDARY outcome
Timeframe: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).Population: Full analysis set included all participants who received any amount of any study intervention.
Progression-free survival is defined as the time from the date of first dose to documented disease progression, or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Cohort 1 Non-NK PTCL
n=31 Participants
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=2 Participants
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=19 Participants
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
1.8 Months
Interval 1.51 to 2.17
|
0.7 Months
Interval 0.66 to
Here, "NA" indicates that higher limit of 95% CI could not be evaluated due to smaller number of participants.
|
1.9 Months
Interval 1.64 to 4.11
|
SECONDARY outcome
Timeframe: From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).Population: Full analysis set included all participants who received any amount of any study intervention.
Overall survival is defined as the time from the date of first dose to death from any cause.
Outcome measures
| Measure |
Cohort 1 Non-NK PTCL
n=31 Participants
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=2 Participants
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=19 Participants
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Overall Survival (OS)
|
8.6 Months
Interval 2.33 to 10.18
|
NA Months
Interval 0.66 to
Here, "NA" indicates that median and higher limit of 95% CI could not be evaluated due to smaller number of participants.
|
NA Months
Interval 10.05 to
Here "NA" indicates that the median and upper limit of 95% CI could not be calculated due to less number of events of interest (less than 50%).
|
SECONDARY outcome
Timeframe: From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).Population: Safety set included all participants who received at least 1 dose of any study intervention.
The safety and tolerability of AZD4573 was assessed.
Outcome measures
| Measure |
Cohort 1 Non-NK PTCL
n=31 Participants
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=2 Participants
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=19 Participants
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AE) and Serious AEs (SAE)
Any AE
|
31 Participants
|
2 Participants
|
18 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious AEs (SAE)
Any AE possibly related to treatment
|
31 Participants
|
2 Participants
|
16 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious AEs (SAE)
Any AE of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher
|
29 Participants
|
2 Participants
|
15 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious AEs (SAE)
Any AE of CTCAE grade 3 or higher, possibly related to treatment
|
27 Participants
|
2 Participants
|
13 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious AEs (SAE)
Any AE with outcome = death
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious AEs (SAE)
Any AE with outcome = death, possibly related to treatment
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious AEs (SAE)
Any SAE (including events with outcome = death)
|
21 Participants
|
2 Participants
|
11 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious AEs (SAE)
Any SAE (including events with outcome = death), possibly related to treatment
|
16 Participants
|
1 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.Population: Pharmacokinetic (PK) set included all participants who received any amount of study intervention with at least 1 reportable concentration. Here, 'n" (number analyzed in each row) signifies the participants with available data that were analyzed for each timepoint of this outcome measure.
The plasma PK of AZD4573 when administered in participants was assessed.
Outcome measures
| Measure |
Cohort 1 Non-NK PTCL
n=31 Participants
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=2 Participants
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=19 Participants
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Maximum Observed Plasma (Peak) Drug Concentration (Cmax)
Cycle 1 week 2 day 1
|
312.4 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 84.5
|
NA Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
278.2 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 73.8
|
|
Maximum Observed Plasma (Peak) Drug Concentration (Cmax)
Cycle 1 week 1 day 1
|
159.9 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 53.2
|
NA Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
201.8 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 82.1
|
|
Maximum Observed Plasma (Peak) Drug Concentration (Cmax)
Cycle 1 week 3 day 1
|
265.5 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 54.1
|
NA Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
376.3 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 89.9
|
|
Maximum Observed Plasma (Peak) Drug Concentration (Cmax)
Cycle 2 day 1
|
308.6 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 65.9
|
—
|
381.8 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 82.5
|
SECONDARY outcome
Timeframe: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.Population: PK set included all participants who received any amount of study intervention with at least 1 reportable concentration. Here, 'n" (number analyzed in each row) signifies the participants with available data that were analyzed for each timepoint of this outcome measure.
The plasma PK of AZD4573 when administered in participants was assessed.
Outcome measures
| Measure |
Cohort 1 Non-NK PTCL
n=31 Participants
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=2 Participants
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=19 Participants
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Area Under the Plasma Concentration Curve From Zero to the Last Quantifiable Concentration (AUClast)
Cycle 1 week 1 day 1
|
913.3 hours (h)*ng/mL
Geometric Coefficient of Variation 95.0
|
NA hours (h)*ng/mL
Geometric Coefficient of Variation NA
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
1039 hours (h)*ng/mL
Geometric Coefficient of Variation 113.5
|
|
Area Under the Plasma Concentration Curve From Zero to the Last Quantifiable Concentration (AUClast)
Cycle 1 week 2 day 1
|
1695 hours (h)*ng/mL
Geometric Coefficient of Variation 102.3
|
NA hours (h)*ng/mL
Geometric Coefficient of Variation NA
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
1646 hours (h)*ng/mL
Geometric Coefficient of Variation 86.7
|
|
Area Under the Plasma Concentration Curve From Zero to the Last Quantifiable Concentration (AUClast)
Cycle 1 week 3 day 1
|
1651 hours (h)*ng/mL
Geometric Coefficient of Variation 76.5
|
NA hours (h)*ng/mL
Geometric Coefficient of Variation NA
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
2228 hours (h)*ng/mL
Geometric Coefficient of Variation 75.0
|
|
Area Under the Plasma Concentration Curve From Zero to the Last Quantifiable Concentration (AUClast)
Cycle 2 day 1
|
1933 hours (h)*ng/mL
Geometric Coefficient of Variation 81.2
|
—
|
2083 hours (h)*ng/mL
Geometric Coefficient of Variation 115.9
|
SECONDARY outcome
Timeframe: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.Population: PK set included all participants who received any amount of study intervention with at least 1 reportable concentration. Here, 'n" (number analyzed in each row) signifies the participants with available data that were analyzed for each timepoint of this outcome measure.
The plasma PK of AZD4573 when administered in participants was assessed.
Outcome measures
| Measure |
Cohort 1 Non-NK PTCL
n=18 Participants
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=1 Participants
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=12 Participants
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-inf) of AZD4573
Cycle 1 week 1 day 1
|
1294 h*ng/mL
Geometric Coefficient of Variation 82.9
|
—
|
1872 h*ng/mL
Geometric Coefficient of Variation 59.3
|
|
Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-inf) of AZD4573
Cycle 1 week 2 day 1
|
1711 h*ng/mL
Geometric Coefficient of Variation 86.8
|
NA h*ng/mL
Geometric Coefficient of Variation NA
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
1984 h*ng/mL
Geometric Coefficient of Variation 62.9
|
|
Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-inf) of AZD4573
Cycle 1 week 3 day 1
|
1490 h*ng/mL
Geometric Coefficient of Variation 71.5
|
NA h*ng/mL
Geometric Coefficient of Variation NA
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
2643 h*ng/mL
Geometric Coefficient of Variation 88.2
|
|
Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-inf) of AZD4573
Cycle 2 day 1
|
1885 h*ng/mL
Geometric Coefficient of Variation 72.9
|
—
|
1899 h*ng/mL
Geometric Coefficient of Variation 89.0
|
SECONDARY outcome
Timeframe: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.Population: PK set included all participants who received any amount of study intervention with at least 1 reportable concentration. Here, 'n" (number analyzed in each row) signifies the participants with available data that were analyzed for each timepoint of this outcome measure.
The plasma PK of AZD4573 when administered in participants was assessed.
Outcome measures
| Measure |
Cohort 1 Non-NK PTCL
n=31 Participants
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=2 Participants
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=19 Participants
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Time to Reach Peak Observed Concentration Following Drug Administration (Tmax)
Cycle 1 week 1 day 1
|
2.000 Hour
Interval 0.97 to 6.0
|
NA Hour
Interval 1.9 to 2.15
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
2.083 Hour
Interval 1.0 to 23.0
|
|
Time to Reach Peak Observed Concentration Following Drug Administration (Tmax)
Cycle 1 week 2 day 1
|
2.083 Hour
Interval 1.87 to 6.08
|
NA Hour
Interval 2.15 to 2.15
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
2.083 Hour
Interval 1.87 to 6.0
|
|
Time to Reach Peak Observed Concentration Following Drug Administration (Tmax)
Cycle 1 week 3 day 1
|
2.083 Hour
Interval 0.87 to 6.0
|
NA Hour
Interval 2.25 to 2.25
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
2.133 Hour
Interval 1.78 to 4.0
|
|
Time to Reach Peak Observed Concentration Following Drug Administration (Tmax)
Cycle 2 day 1
|
2.133 Hour
Interval 1.0 to 3.58
|
—
|
2.083 Hour
Interval 0.97 to 5.02
|
SECONDARY outcome
Timeframe: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.Population: PK set included all participants who received any amount of study intervention with at least 1 reportable concentration. Here, 'n" (number analyzed in each row) signifies the participants with available data that were analyzed for each timepoint of this outcome measure.
The plasma PK of AZD4573 when administered in participants was assessed.
Outcome measures
| Measure |
Cohort 1 Non-NK PTCL
n=18 Participants
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=1 Participants
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=12 Participants
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Half-life (t1/2) of AZD4573
Cycle 1 week 1 day 1
|
5.772 Hour
Interval 1.67 to 11.6
|
—
|
5.858 Hour
Interval 3.68 to 7.9
|
|
Half-life (t1/2) of AZD4573
Cycle 1 week 2 day 1
|
5.448 Hour
Interval 4.1 to 11.3
|
NA Hour
Interval 6.8 to 6.8
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
5.250 Hour
Interval 4.11 to 9.71
|
|
Half-life (t1/2) of AZD4573
Cycle 1 week 3 day 1
|
5.435 Hour
Interval 1.15 to 10.5
|
NA Hour
Interval 5.09 to 5.09
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
5.499 Hour
Interval 3.93 to 23.5
|
|
Half-life (t1/2) of AZD4573
Cycle 2 day 1
|
6.669 Hour
Interval 3.5 to 16.0
|
—
|
4.323 Hour
Interval 3.56 to 14.7
|
SECONDARY outcome
Timeframe: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.Population: PK set included all participants who received any amount of study intervention with at least 1 reportable concentration. Here, 'n" (number analyzed in each row) signifies the participants with available data that were analyzed for each timepoint of this outcome measure.
The plasma PK of AZD4573 when administered in participants was assessed.
Outcome measures
| Measure |
Cohort 1 Non-NK PTCL
n=18 Participants
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=1 Participants
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=11 Participants
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Systematic Clearance (CL)
Cycle 1 week 3 day 1
|
7.799 Liter/hour
Geometric Coefficient of Variation 69.5
|
NA Liter/hour
Geometric Coefficient of Variation NA
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
4.965 Liter/hour
Geometric Coefficient of Variation 74.7
|
|
Systematic Clearance (CL)
Cycle 1 week 1 day 1
|
4.636 Liter/hour
Geometric Coefficient of Variation 82.9
|
—
|
3.205 Liter/hour
Geometric Coefficient of Variation 59.3
|
|
Systematic Clearance (CL)
Cycle 1 week 2 day 1
|
5.137 Liter/hour
Geometric Coefficient of Variation 82.3
|
NA Liter/hour
Geometric Coefficient of Variation NA
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
4.537 Liter/hour
Geometric Coefficient of Variation 62.9
|
|
Systematic Clearance (CL)
Cycle 2 day 1
|
6.367 Liter/hour
Geometric Coefficient of Variation 72.9
|
—
|
6.064 Liter/hour
Geometric Coefficient of Variation 85.9
|
SECONDARY outcome
Timeframe: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.Population: PK set included all participants who received any amount of study intervention with at least 1 reportable concentration. Here, 'n" (number analyzed in each row) signifies the participants with available data that were analyzed for each timepoint of this outcome measure.
The plasma PK of AZD4573 when administered in participants was assessed.
Outcome measures
| Measure |
Cohort 1 Non-NK PTCL
n=18 Participants
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=1 Participants
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=11 Participants
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Volume of Distribution at Terminal Phase (Vz)
Cycle 1 week 1 day 1
|
38.59 Liter
Geometric Coefficient of Variation 49.0
|
—
|
26.45 Liter
Geometric Coefficient of Variation 54.2
|
|
Volume of Distribution at Terminal Phase (Vz)
Cycle 1 week 2 day 1
|
45.96 Liter
Geometric Coefficient of Variation 53.8
|
NA Liter
Geometric Coefficient of Variation NA
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
37.68 Liter
Geometric Coefficient of Variation 37.5
|
|
Volume of Distribution at Terminal Phase (Vz)
Cycle 1 week 3 day 1
|
58.92 Liter
Geometric Coefficient of Variation 33.1
|
NA Liter
Geometric Coefficient of Variation NA
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
44.34 Liter
Geometric Coefficient of Variation 55.7
|
|
Volume of Distribution at Terminal Phase (Vz)
Cycle 2 day 1
|
63.45 Liter
Geometric Coefficient of Variation 41.6
|
—
|
43.38 Liter
Geometric Coefficient of Variation 59.0
|
SECONDARY outcome
Timeframe: Cycle 1 (Cycle length is 35 days), Day 1 of Weeks 1-3 and Cycle 2 (Cycle length is 21 Days), Day 1.Population: PK set included all participants who received any amount of study intervention with at least 1 reportable concentration. Here, 'n" (number analyzed in each row) signifies the participants with available data that were analyzed for each timepoint of this outcome measure.
The plasma PK of AZD4573 when administered in participants was assessed.
Outcome measures
| Measure |
Cohort 1 Non-NK PTCL
n=18 Participants
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=1 Participants
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=11 Participants
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Volume of Distribution at Steady State (Vss)
Cycle 1 week 1 day 1
|
35.80 Liter
Geometric Coefficient of Variation 51.1
|
—
|
24.20 Liter
Geometric Coefficient of Variation 54.3
|
|
Volume of Distribution at Steady State (Vss)
Cycle 1 week 2 day 1
|
39.25 Liter
Geometric Coefficient of Variation 51.3
|
NA Liter
Geometric Coefficient of Variation NA
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
33.20 Liter
Geometric Coefficient of Variation 36.9
|
|
Volume of Distribution at Steady State (Vss)
Cycle 1 week 3 day 1
|
50.32 Liter
Geometric Coefficient of Variation 27.8
|
NA Liter
Geometric Coefficient of Variation NA
Here, "NA" indicates that data could not be evaluated due to smaller number of participants.
|
37.99 Liter
Geometric Coefficient of Variation 66.3
|
|
Volume of Distribution at Steady State (Vss)
Cycle 2 day 1
|
55.93 Liter
Geometric Coefficient of Variation 36.8
|
—
|
37.29 Liter
Geometric Coefficient of Variation 54.6
|
Adverse Events
Cohort 1 Non-NK PTCL
Serious events: 21 serious events
Other events: 31 other events
Deaths: 17 deaths
Cohort 2 NK PTCL
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Cohort 3 cHL
Serious events: 11 serious events
Other events: 18 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort 1 Non-NK PTCL
n=31 participants at risk
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=2 participants at risk
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=19 participants at risk
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
50.0%
1/2 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Nervous system disorders
Syncope
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
50.0%
1/2 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Vascular disorders
Hypotension
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
COVID-19
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Escherichia sepsis
|
12.9%
4/31 • Number of events 4 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Infection
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Pneumonia viral
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
6.5%
2/31 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Staphylococcal sepsis
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.9%
4/31 • Number of events 4 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
15.8%
3/19 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Hepatobiliary disorders
Liver injury
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Renal and urinary disorders
Fanconi syndrome acquired
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
General disorders
Chills
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
General disorders
Pyrexia
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Alanine aminotransferase increased
|
9.7%
3/31 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Aspartate aminotransferase increased
|
9.7%
3/31 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
50.0%
1/2 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Blood bilirubin increased
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
10.5%
2/19 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
C-reactive protein increased
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Liver function test increased
|
6.5%
2/31 • Number of events 9 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Transaminases increased
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
White blood cell count decreased
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
Other adverse events
| Measure |
Cohort 1 Non-NK PTCL
n=31 participants at risk
Participants with non-NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 2 NK PTCL
n=2 participants at risk
Participants with NK PTCL received 12 mg dose of AZD4573 once weekly until disease progression.
|
Cohort 3 cHL
n=19 participants at risk
Participants with cHL received 12 mg dose of AZD4573 once weekly until disease progression.
|
|---|---|---|---|
|
Infections and infestations
Bacteraemia
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
COVID-19
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Herpes zoster
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Influenza
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Pneumonia
|
12.9%
4/31 • Number of events 4 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
15.8%
3/19 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Urinary tract infection
|
6.5%
2/31 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
50.0%
1/2 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Infections and infestations
Vascular device infection
|
3.2%
1/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Blood and lymphatic system disorders
Anaemia
|
35.5%
11/31 • Number of events 21 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
52.6%
10/19 • Number of events 15 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.5%
2/31 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.7%
3/31 • Number of events 4 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 7 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Blood and lymphatic system disorders
Neutropenia
|
77.4%
24/31 • Number of events 126 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
50.0%
1/2 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
68.4%
13/19 • Number of events 54 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
41.9%
13/31 • Number of events 43 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
50.0%
1/2 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
21.1%
4/19 • Number of events 9 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
50.0%
1/2 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Immune system disorders
Serum sickness
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
10.5%
2/19 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
50.0%
1/2 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
10.5%
2/19 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.5%
2/31 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.5%
2/31 • Number of events 5 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
10.5%
2/19 • Number of events 5 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
16.1%
5/31 • Number of events 9 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.8%
8/31 • Number of events 16 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
35.5%
11/31 • Number of events 14 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
50.0%
1/2 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
21.1%
4/19 • Number of events 6 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.9%
4/31 • Number of events 5 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.5%
2/31 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.9%
4/31 • Number of events 8 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
10.5%
2/19 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Psychiatric disorders
Anxiety
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Nervous system disorders
Dizziness
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
15.8%
3/19 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Nervous system disorders
Headache
|
6.5%
2/31 • Number of events 4 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
21.1%
4/19 • Number of events 6 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Eye disorders
Dry eye
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Eye disorders
Eye pain
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Eye disorders
Vision blurred
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Vascular disorders
Hypotension
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
50.0%
1/2 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
10.5%
2/19 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
21.1%
4/19 • Number of events 4 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
15.8%
3/19 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
9.7%
3/31 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.5%
2/31 • Number of events 4 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Gastrointestinal disorders
Constipation
|
19.4%
6/31 • Number of events 6 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
26.3%
5/19 • Number of events 5 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Gastrointestinal disorders
Diarrhoea
|
38.7%
12/31 • Number of events 18 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
36.8%
7/19 • Number of events 8 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Gastrointestinal disorders
Nausea
|
32.3%
10/31 • Number of events 14 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
50.0%
1/2 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
47.4%
9/19 • Number of events 14 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Gastrointestinal disorders
Stomatitis
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Gastrointestinal disorders
Vomiting
|
25.8%
8/31 • Number of events 10 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
10.5%
2/19 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
10.5%
2/19 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
15.8%
3/19 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.7%
3/31 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
10.5%
2/19 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.5%
2/31 • Number of events 4 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Skin and subcutaneous tissue disorders
Skin weeping
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.7%
3/31 • Number of events 4 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
10.5%
2/19 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.9%
4/31 • Number of events 5 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
General disorders
Catheter site thrombosis
|
9.7%
3/31 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
General disorders
Chills
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
General disorders
Fatigue
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
31.6%
6/19 • Number of events 6 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
General disorders
Influenza like illness
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
General disorders
Mucosal inflammation
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
General disorders
Non-cardiac chest pain
|
6.5%
2/31 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
General disorders
Oedema peripheral
|
9.7%
3/31 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
General disorders
Pain
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
General disorders
Pyrexia
|
16.1%
5/31 • Number of events 16 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
50.0%
1/2 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
15.8%
3/19 • Number of events 5 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Alanine aminotransferase increased
|
61.3%
19/31 • Number of events 90 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
50.0%
1/2 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
57.9%
11/19 • Number of events 35 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Amylase increased
|
9.7%
3/31 • Number of events 6 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
10.5%
2/19 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Aspartate aminotransferase increased
|
67.7%
21/31 • Number of events 101 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
100.0%
2/2 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
57.9%
11/19 • Number of events 42 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Bilirubin conjugated increased
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Blood alkaline phosphatase increased
|
9.7%
3/31 • Number of events 5 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
10.5%
2/19 • Number of events 5 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Blood bilirubin increased
|
45.2%
14/31 • Number of events 46 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
100.0%
2/2 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
26.3%
5/19 • Number of events 18 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Blood calcium decreased
|
3.2%
1/31 • Number of events 4 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Blood cholesterol increased
|
3.2%
1/31 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Blood creatinine increased
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Blood fibrinogen increased
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Blood phosphorus decreased
|
9.7%
3/31 • Number of events 4 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Blood phosphorus increased
|
12.9%
4/31 • Number of events 6 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
10.5%
2/19 • Number of events 5 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Blood potassium decreased
|
6.5%
2/31 • Number of events 5 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Blood potassium increased
|
9.7%
3/31 • Number of events 4 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Blood triglycerides increased
|
6.5%
2/31 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Blood urea increased
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Fibrin D dimer increased
|
3.2%
1/31 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
10.5%
2/19 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Gamma-glutamyltransferase increased
|
32.3%
10/31 • Number of events 18 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
21.1%
4/19 • Number of events 7 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
International normalised ratio increased
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Lipase increased
|
6.5%
2/31 • Number of events 4 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Lymphocyte count decreased
|
6.5%
2/31 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Prothrombin time prolonged
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Serum ferritin increased
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Transaminases increased
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
10.5%
2/19 • Number of events 3 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
Troponin increased
|
6.5%
2/31 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/19 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Investigations
White blood cell count decreased
|
19.4%
6/31 • Number of events 34 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/31 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
0.00%
0/2 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
5.3%
1/19 • Number of events 1 • From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
- Publication restrictions are in place
Restriction type: OTHER