Trial Outcomes & Findings for Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC (NCT NCT03822351)
NCT ID: NCT03822351
Last Updated: 2024-10-08
Results Overview
ORR was defined as the percentage of participants with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
189 participants
Primary outcome timeframe
ORR at 16 weeks after randomization is the timing for radiologic assessment of the primary endpoint
Results posted on
2024-10-08
Participant Flow
The first participant was randomized into the study on 3 January 2019 and the last participant was randomized on 6 July 2020.
Participant milestones
| Measure |
Control Arm (Durvalumab Monotherapy)
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
|---|---|---|---|
|
Overall Study
STARTED
|
67
|
60
|
62
|
|
Overall Study
COMPLETED
|
21
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
46
|
31
|
32
|
Reasons for withdrawal
| Measure |
Control Arm (Durvalumab Monotherapy)
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
|---|---|---|---|
|
Overall Study
Death
|
27
|
23
|
24
|
|
Overall Study
Lost to Follow-up
|
6
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
4
|
6
|
|
Overall Study
Progressive Disease
|
2
|
1
|
0
|
|
Overall Study
Not Treated
|
1
|
1
|
1
|
Baseline Characteristics
Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC
Baseline characteristics by cohort
| Measure |
Control Arm (Durvalumab Monotherapy)
n=67 Participants
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
n=60 Participants
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
n=62 Participants
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
64.4 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
57 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Region of Enrollment
Hong-Kong
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
Portugal
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: ORR at 16 weeks after randomization is the timing for radiologic assessment of the primary endpointPopulation: The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group
ORR was defined as the percentage of participants with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
Outcome measures
| Measure |
Control Arm (Durvalumab Monotherapy)
n=67 Participants
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
n=60 Participants
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
n=62 Participants
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
|---|---|---|---|
|
Objective Response (OR) Rate as a Measure of Antitumor Activity of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
|
23.9 Percentage of Participants
Interval 14.3 to 35.9
|
35.0 Percentage of Participants
Interval 23.1 to 48.4
|
40.3 Percentage of Participants
Interval 28.1 to 53.6
|
SECONDARY outcome
Timeframe: From time of signature of informed consent up to 15 months post the first dose of study treatmentPopulation: The As-treated population included all participants who receive any IP. Participants were analyzed according to the treatment they received.
The secondary endpoint of safety as assessed by the presence of adverse events and serious adverse events
Outcome measures
| Measure |
Control Arm (Durvalumab Monotherapy)
n=66 Participants
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
n=59 Participants
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
n=61 Participants
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
|---|---|---|---|
|
Presence of Adverse Events as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any TEAEs
|
65 Participants
|
57 Participants
|
61 Participants
|
|
Presence of Adverse Events as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any serious TEAEs
|
23 Participants
|
20 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From baseline up to 15 months post the first dose of study treatmentPopulation: The As-treated population included all participants who receive any IP. Participants were analyzed according to the treatment they received.
The secondary endpoint of safety as assessed by the presence of Grade 3 or 4 clinical laboratory toxicities (based on NCI-CTCAE v5.0) in chemistry and hematology values
Outcome measures
| Measure |
Control Arm (Durvalumab Monotherapy)
n=66 Participants
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
n=59 Participants
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
n=61 Participants
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
|---|---|---|---|
|
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any Grade 3 or 4 Amylase (U/L) toxicities
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any Grade 3 or 4 Creatinine Clearance Rate (mL/min) toxicities
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any Grade 3 or 4 Lymphocyte count increased (10^3/uL) toxicities
|
19 Participants
|
11 Participants
|
11 Participants
|
|
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any Grade 3 or 4 Gamma Glutamyl Transferase (U/L) toxicities
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any Grade 3 or 4 Hyperkalemia (mEq/L) toxicities
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any Grade 3 or 4 Hypokalemia (mEq/L) toxicities
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any Grade 3 or 4 Hypocalcemia (corrected) (mg/dL) toxicities
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any Grade 3 or 4 Hypernatremia (mEq/L) toxicities
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any Grade 3 or 4 Lipase (U/L) toxicities
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any Grade 3 or 4 Hemoglobin increased (g/dL) toxicities
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any Grade 3 or 4 Platelet count decreased (10^3/uL) toxicities
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any Grade 3 or 4 Alanine Aminostransferase (U/L) toxicities
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any Grade 3 or 4 Albumin (g/dL) toxicities
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any Grade 3 or 4 Aspartate Aminotransferase (U/L) toxicities
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Participants with any Grade 3 or 4 Creatinine (mg/dL) toxicities
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline up to 15 months post the first dose of study treatmentPopulation: The As-treated population included all participants who receive any IP. Participants were analyzed according to the treatment they received.
The secondary endpoint of safety as assessed by the presence of abnormal vital signs reported as adverse events
Outcome measures
| Measure |
Control Arm (Durvalumab Monotherapy)
n=66 Participants
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
n=59 Participants
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
n=61 Participants
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
|---|---|---|---|
|
Presence of Abnormalities in Vital Signs as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Hypertension
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Presence of Abnormalities in Vital Signs as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Hypotension
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Presence of Abnormalities in Vital Signs as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Tachycardia
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Presence of Abnormalities in Vital Signs as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Palpitations
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Presence of Abnormalities in Vital Signs as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
Pyrexia
|
6 Participants
|
8 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).Population: The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group. Only participants with an objective response were included in the DoR analysis.
The duration from the first documentation of a subsequently confirmed OR to the first documentation of a disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first. Only participants who have achieved OR (confirmed CR or confirmed PR) will be evaluated for DoR
Outcome measures
| Measure |
Control Arm (Durvalumab Monotherapy)
n=16 Participants
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
n=21 Participants
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
n=25 Participants
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
|---|---|---|---|
|
Duration of Response (DoR) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
|
NA Months
Interval 14.1 to
The median and upper limit of 95% CI could not be calculated as they were not reached.
|
29.9 Months
Interval 17.1 to
The upper limit of 95% CI could not be calculated as it was not reached.
|
23.0 Months
Interval 10.2 to
The upper limit of 95% CI could not be calculated as it was not reached.
|
SECONDARY outcome
Timeframe: Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).Population: The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group
Disease control rate (DCR) was defined as the percentage of participants with a BOR of confirmed CR, confirmed PR, or SD (maintained for ≥ 16 weeks) based on RECIST v1.1.
Outcome measures
| Measure |
Control Arm (Durvalumab Monotherapy)
n=67 Participants
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
n=60 Participants
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
n=62 Participants
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
|---|---|---|---|
|
Disease Control (DC) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
|
58.2 Percentage of Participants
Interval 45.5 to 70.2
|
80.0 Percentage of Participants
Interval 67.7 to 89.2
|
79.0 Percentage of Participants
Interval 66.8 to 88.3
|
SECONDARY outcome
Timeframe: Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).Population: The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group
PFS was defined as the time from randomization until the first documentation of disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first
Outcome measures
| Measure |
Control Arm (Durvalumab Monotherapy)
n=67 Participants
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
n=60 Participants
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
n=62 Participants
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
|---|---|---|---|
|
Progression-Free Survival (PFS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
|
7.3 Months
Interval 4.0 to 13.8
|
21.1 Months
Interval 10.4 to 30.9
|
19.8 Months
Interval 13.6 to 31.3
|
SECONDARY outcome
Timeframe: PFS rate at 12 months after randomization.Population: The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group
PFS-12 was defined as the percentage of participants who were alive and progression free at 12 months after randomization.
Outcome measures
| Measure |
Control Arm (Durvalumab Monotherapy)
n=67 Participants
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
n=60 Participants
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
n=62 Participants
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
|---|---|---|---|
|
Progression-Free Survival 12 Month Landmark Rate (PFS-12) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
|
37.6 Percentage of Participants
Interval 24.7 to 50.4
|
63.5 Percentage of Participants
Interval 49.2 to 74.7
|
73.2 Percentage of Participants
Interval 59.6 to 82.9
|
SECONDARY outcome
Timeframe: From time of randomization until death due to any cause. Assessed through the database cutoff date of 18-Jul-2023).Population: The Intent-to-treat (ITT) population included participants who were randomized and were analyzed according to their randomized treatment group
OS was defined as the time from the date of randomization until death due to any cause.
Outcome measures
| Measure |
Control Arm (Durvalumab Monotherapy)
n=67 Participants
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
n=60 Participants
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
n=62 Participants
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
|---|---|---|---|
|
Overall Survival (OS) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
|
40.9 Months
Interval 22.6 to
The upper limit of 95% CI could not be calculated as it was not reached.
|
NA Months
Interval 31.9 to
The median and upper limit of 95% CI could not be calculated as they were not reached.
|
NA Months
Interval 31.3 to
The median and upper limit of 95% CI could not be calculated as they were not reached.
|
SECONDARY outcome
Timeframe: From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose and at end of infusion, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1Population: The PK-evaluable durvalumab population included participants from the As-treated population who had a non-missing baseline PK durvalumab concentration and at least one non-missing post-baseline PK durvalumab concentration
Geometric mean serum concentrations of durvalumab (μg/mL) were reported for each time point where data warrant, as appropriate.
Outcome measures
| Measure |
Control Arm (Durvalumab Monotherapy)
n=57 Participants
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
n=41 Participants
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
n=51 Participants
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
|---|---|---|---|
|
Pharmacokinetics of Durvalumab Alone and in Combination With Novel Agents
Cycle 1 Day 1: End of Infusion
|
318.0 Micrograms per milliliter
Geometric Coefficient of Variation 199.6
|
277.4 Micrograms per milliliter
Geometric Coefficient of Variation 316.1
|
223.7 Micrograms per milliliter
Geometric Coefficient of Variation 1272
|
|
Pharmacokinetics of Durvalumab Alone and in Combination With Novel Agents
Cycle 2 Day 1: Pre-Dose
|
59.7 Micrograms per milliliter
Geometric Coefficient of Variation 58.6
|
68.0 Micrograms per milliliter
Geometric Coefficient of Variation 49.9
|
74.3 Micrograms per milliliter
Geometric Coefficient of Variation 40.7
|
|
Pharmacokinetics of Durvalumab Alone and in Combination With Novel Agents
Cycle 7 Day 1: Pre-Dose
|
151.6 Micrograms per milliliter
Geometric Coefficient of Variation 37.7
|
127.9 Micrograms per milliliter
Geometric Coefficient of Variation 66.4
|
176.5 Micrograms per milliliter
Geometric Coefficient of Variation 45.6
|
|
Pharmacokinetics of Durvalumab Alone and in Combination With Novel Agents
Cycle 11 Day 1: Pre-Dose
|
156.7 Micrograms per milliliter
Geometric Coefficient of Variation 50.0
|
146.5 Micrograms per milliliter
Geometric Coefficient of Variation 91.3
|
172.4 Micrograms per milliliter
Geometric Coefficient of Variation 40.4
|
SECONDARY outcome
Timeframe: From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose and at end of infusion, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1Population: The PK-evaluable oleclumab/monalizumab population included participants from the As-treated population who had a non-missing baseline PK oleclumab/monalizumab concentration and at least one non-missing post-baseline PK oleclumab/monalizumab concentration
Geometric mean serum concentrations of oleclumab (μg/mL) and monalizumab (μg/mL) were reported for each time point where data warrant, as appropriate.
Outcome measures
| Measure |
Control Arm (Durvalumab Monotherapy)
n=52 Participants
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
n=51 Participants
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
|---|---|---|---|
|
Pharmacokinetics of Novel Agents in Combination With Durvalumab
Cycle 11 Day 1: Pre-Dose
|
132.0 Micrograms per milliliter
Geometric Coefficient of Variation 166.8
|
196.2 Micrograms per milliliter
Geometric Coefficient of Variation 48.7
|
—
|
|
Pharmacokinetics of Novel Agents in Combination With Durvalumab
Cycle 1 Day 1: End of Infusion
|
581.6 Micrograms per milliliter
Geometric Coefficient of Variation 210.5
|
160.0 Micrograms per milliliter
Geometric Coefficient of Variation 286.4
|
—
|
|
Pharmacokinetics of Novel Agents in Combination With Durvalumab
Cycle 2 Day 1: Pre-Dose
|
216.4 Micrograms per milliliter
Geometric Coefficient of Variation 58.6
|
102.6 Micrograms per milliliter
Geometric Coefficient of Variation 39.2
|
—
|
|
Pharmacokinetics of Novel Agents in Combination With Durvalumab
Cycle 7 Day 1: Pre-Dose
|
124.5 Micrograms per milliliter
Geometric Coefficient of Variation 109.0
|
194.5 Micrograms per milliliter
Geometric Coefficient of Variation 33.8
|
—
|
SECONDARY outcome
Timeframe: From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1Population: The durvalumab ADA-evaluable population included participants from the As-treated population who had a non-missing baseline durvalumab ADA result and at least one non-missing post-baseline durvalumab ADA result
ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. ADA incidence (treatment-emergent ADA positive) was defined as the sum of treatment-induced ADA and treatment-boosted ADA.
Outcome measures
| Measure |
Control Arm (Durvalumab Monotherapy)
n=40 Participants
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
n=18 Participants
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
n=33 Participants
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
|---|---|---|---|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Durvalumab Alone and in Combination With Novel Agents
ADA positive at any visit (ADA prevalence)
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Durvalumab Alone and in Combination With Novel Agents
Treatment-emergent ADA positive (ADA incidence)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Durvalumab Alone and in Combination With Novel Agents
Treatment-boosted ADA
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Durvalumab Alone and in Combination With Novel Agents
Treatment-induced ADA (positive post-baseline only)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Durvalumab Alone and in Combination With Novel Agents
ADA positive at baseline only
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Durvalumab Alone and in Combination With Novel Agents
Persistently positive
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Durvalumab Alone and in Combination With Novel Agents
Transiently positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Durvalumab Alone and in Combination With Novel Agents
ADA positive post-baseline and positive at baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization up to 15 months after first treatment: Cycle 1 Day 1 pre-dose, Cycle 2 Day 1 pre-dose (1 month), Cycle 7 Day 1 pre-dose (6 months), Cycle 11 Day 1 pre-dose (10 months) and 15 months post Cycle 1 Day 1Population: The oleclumab/monalizumab ADA-evaluable population included participants from the As-treated population who had a non-missing baseline oleclumab/monalizumab ADA result and at least one non-missing post-baseline oleclumab/monalizumab ADA result
ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. ADA incidence (treatment-emergent ADA positive) was defined as the sum of treatment-induced ADA and treatment-boosted ADA.
Outcome measures
| Measure |
Control Arm (Durvalumab Monotherapy)
n=54 Participants
Durvalumab 1500 mg IV monotherapy Q4W
|
Arm A (Durvalumab + Oleclumab)
n=51 Participants
Durvalumab 1500 mg IV Q4W + Oleclumab 3000 mg IV (Q2W for cycles 1 and 2, then Q4W starting cycle 3)
|
Arm B (Durvalumab + Monalizumab)
Durvalumab 1500 mg IV Q4W + Monalizumab 750 mg IV Q2W
|
|---|---|---|---|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Novel Agents in Combination With Durvalumab
Treatment-emergent ADA positive (ADA incidence)
|
0 Participants
|
1 Participants
|
—
|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Novel Agents in Combination With Durvalumab
Transiently positive
|
0 Participants
|
1 Participants
|
—
|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Novel Agents in Combination With Durvalumab
ADA positive at any visit (ADA prevalence)
|
0 Participants
|
1 Participants
|
—
|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Novel Agents in Combination With Durvalumab
Treatment-boosted ADA
|
0 Participants
|
0 Participants
|
—
|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Novel Agents in Combination With Durvalumab
Treatment-induced ADA (positive post-baseline only)
|
0 Participants
|
1 Participants
|
—
|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Novel Agents in Combination With Durvalumab
ADA positive at baseline only
|
0 Participants
|
0 Participants
|
—
|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Novel Agents in Combination With Durvalumab
ADA positive post-baseline and positive at baseline
|
0 Participants
|
0 Participants
|
—
|
|
Presence of Detectable Anti-Drug Antibody (ADA) Response to Novel Agents in Combination With Durvalumab
Persistently positive
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Durvalumab Monotherapy
Serious events: 23 serious events
Other events: 61 other events
Deaths: 27 deaths
Durvalumab + Oleclumab
Serious events: 20 serious events
Other events: 52 other events
Deaths: 23 deaths
Durvalumab + Monalizumab
Serious events: 17 serious events
Other events: 58 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Durvalumab Monotherapy
n=66 participants at risk
Description (Arm-group)
|
Durvalumab + Oleclumab
n=59 participants at risk
Description (Arm-group)
|
Durvalumab + Monalizumab
n=61 participants at risk
Description (Arm-group)
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Oesophagobronchial fistula
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
2/66 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.5%
3/66 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
10.2%
6/59 • Number of events 6 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
3.3%
2/61 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Cardiac disorders
Pulmonary valve stenosis
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Anoxia
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
General disorders
Pyrexia
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
General disorders
Sudden death
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Infections and infestations
Device related infection
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Eye disorders
Visual acuity reduced
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Infections and infestations
Periorbital infection
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Infections and infestations
Pneumonia
|
7.6%
5/66 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
6.8%
4/59 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Infections and infestations
Pneumonia bacterial
|
1.5%
1/66 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Infections and infestations
Respiratory tract infection
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Infections and infestations
Septic shock
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
3.4%
2/59 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Cardiac disorders
Pericardial effusion
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
General disorders
Death
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Cardiac disorders
Sinus arrest
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Nervous system disorders
Brain oedema
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Nervous system disorders
Seizure
|
3.0%
2/66 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.0%
2/66 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
Other adverse events
| Measure |
Durvalumab Monotherapy
n=66 participants at risk
Description (Arm-group)
|
Durvalumab + Oleclumab
n=59 participants at risk
Description (Arm-group)
|
Durvalumab + Monalizumab
n=61 participants at risk
Description (Arm-group)
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
4.5%
3/66 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
5.1%
3/59 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Endocrine disorders
Hypothyroidism
|
15.2%
10/66 • Number of events 11 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
13.6%
8/59 • Number of events 8 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
21.3%
13/61 • Number of events 14 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Eye disorders
Dry eye
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
5.1%
3/59 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
3.3%
2/61 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
3/66 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
6.8%
4/59 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
3.3%
2/61 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Gastrointestinal disorders
Constipation
|
15.2%
10/66 • Number of events 10 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
6.8%
4/59 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
3.3%
2/61 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.6%
7/66 • Number of events 9 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
13.6%
8/59 • Number of events 8 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
21.3%
13/61 • Number of events 19 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Gastrointestinal disorders
Nausea
|
12.1%
8/66 • Number of events 10 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.2%
5/61 • Number of events 7 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.6%
5/66 • Number of events 8 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.5%
5/59 • Number of events 9 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Gastrointestinal disorders
Stomatitis
|
6.1%
4/66 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
General disorders
Influenza like illness
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
5.1%
3/59 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
General disorders
Non-cardiac chest pain
|
6.1%
4/66 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.5%
5/59 • Number of events 6 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.2%
5/61 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
General disorders
Oedema peripheral
|
4.5%
3/66 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.2%
5/61 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
General disorders
Pyrexia
|
9.1%
6/66 • Number of events 8 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
11.9%
7/59 • Number of events 8 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
14.8%
9/61 • Number of events 10 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Infections and infestations
Bronchitis
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
6.8%
4/59 • Number of events 9 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Infections and infestations
Herpes zoster
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
6.8%
4/59 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
6.6%
4/61 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.0%
2/66 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
10.2%
6/59 • Number of events 8 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
4.9%
3/61 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.1%
4/66 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
6.8%
4/59 • Number of events 7 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.6%
5/66 • Number of events 6 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
5.1%
3/59 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.2%
5/61 • Number of events 6 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Nervous system disorders
Headache
|
3.0%
2/66 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
6.8%
4/59 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.2%
5/61 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Nervous system disorders
Paraesthesia
|
3.0%
2/66 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.2%
5/61 • Number of events 6 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
11/66 • Number of events 12 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
32.2%
19/59 • Number of events 22 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
42.6%
26/61 • Number of events 29 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.5%
3/66 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
5.1%
3/59 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.1%
4/66 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
2/66 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
5.1%
3/59 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
5.1%
3/59 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/61 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.6%
7/66 • Number of events 7 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
10.2%
6/59 • Number of events 7 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
13.1%
8/61 • Number of events 8 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.6%
7/66 • Number of events 7 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
10.2%
6/59 • Number of events 9 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.2%
5/61 • Number of events 6 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.1%
4/66 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.5%
5/59 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
6.6%
4/61 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.6%
7/66 • Number of events 8 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
16.9%
10/59 • Number of events 17 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
24.6%
15/61 • Number of events 18 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
6/66 • Number of events 7 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
15.3%
9/59 • Number of events 14 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
13.1%
8/61 • Number of events 11 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
3.4%
2/59 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.2%
5/61 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Endocrine disorders
Hyperthyroidism
|
13.6%
9/66 • Number of events 10 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
11.9%
7/59 • Number of events 7 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
9.8%
6/61 • Number of events 6 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Infections and infestations
Pneumonia
|
7.6%
5/66 • Number of events 7 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.2%
5/61 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
2/66 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
5.1%
3/59 • Number of events 7 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Injury, poisoning and procedural complications
Fall
|
7.6%
5/66 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
3.3%
2/61 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
4.5%
3/66 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.5%
5/59 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
4.9%
3/61 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Investigations
Alanine aminotransferase increased
|
4.5%
3/66 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
5.1%
3/59 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
6.6%
4/61 • Number of events 7 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Investigations
Amylase increased
|
10.6%
7/66 • Number of events 13 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
6.8%
4/59 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.2%
5/61 • Number of events 7 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Investigations
Lipase increased
|
9.1%
6/66 • Number of events 11 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.5%
5/59 • Number of events 6 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.2%
5/61 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Investigations
Lymphocyte count decreased
|
6.1%
4/66 • Number of events 7 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
13.6%
8/59 • Number of events 14 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
6/66 • Number of events 6 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
10.2%
6/59 • Number of events 6 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.2%
5/61 • Number of events 6 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.5%
3/66 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
5.1%
3/59 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
11/66 • Number of events 15 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
16.9%
10/59 • Number of events 10 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
18.0%
11/61 • Number of events 14 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
6/66 • Number of events 6 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
10.2%
6/59 • Number of events 6 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
14.8%
9/61 • Number of events 9 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
3/66 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
10.2%
6/59 • Number of events 7 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
3.3%
2/61 • Number of events 2 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
5.1%
3/59 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.2%
5/61 • Number of events 6 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Nervous system disorders
Hypoaesthesia
|
1.5%
1/66 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
6.6%
4/61 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.7%
1/59 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
9.8%
6/61 • Number of events 6 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Psychiatric disorders
Insomnia
|
10.6%
7/66 • Number of events 7 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
5.1%
3/59 • Number of events 4 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
8.2%
5/61 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
5.1%
3/59 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
1.6%
1/61 • Number of events 1 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.8%
17/66 • Number of events 21 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
25.4%
15/59 • Number of events 20 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
23.0%
14/61 • Number of events 18 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/66 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
5.1%
3/59 • Number of events 3 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
4.9%
3/61 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
General disorders
Asthenia
|
15.2%
10/66 • Number of events 11 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
18.6%
11/59 • Number of events 12 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
24.6%
15/61 • Number of events 16 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
General disorders
Fatigue
|
10.6%
7/66 • Number of events 8 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
11.9%
7/59 • Number of events 8 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
14.8%
9/61 • Number of events 9 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
|
Investigations
Blood creatinine increased
|
6.1%
4/66 • Number of events 5 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
0.00%
0/59 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
9.8%
6/61 • Number of events 7 • AEs and SAEs were collected from time of signature of informed consent up to 15 months post the first dose of study treatment
Treatment-emergent adverse events (TEAEs) are defined as events present at baseline that worsen in intensity after administration of study IP or events absent at baseline that emerge after administration of study IP. All TEAEs that occurred on and after first dose up to 3 months after last dose of IP (any) were summarized.
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER