Trial Outcomes & Findings for A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC (NCT NCT05246514)
NCT ID: NCT05246514
Last Updated: 2026-05-12
Results Overview
Confirmed ORR, defined as the percentage of participants with confirmed complete response or partial response, as assessed by independent central review(ICR) based on RECIST 1.1.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. (from date of enrolment to final analysis data cut-off)
Results posted on
2026-05-12
Participant Flow
Participant milestones
| Measure |
T-DXd Arm
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
Overall Study
STARTED
|
72
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
43
|
Reasons for withdrawal
| Measure |
T-DXd Arm
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
Overall Study
Death
|
41
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC
Baseline characteristics by cohort
| Measure |
T-DXd Arm
n=72 Participants
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
Age, Continuous
|
57.4 Years
STANDARD_DEVIATION 9.74 • n=1512 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=1512 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=1512 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Asian
|
72 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
PRIMARY outcome
Timeframe: Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. (from date of enrolment to final analysis data cut-off)Population: Full analysis set
Confirmed ORR, defined as the percentage of participants with confirmed complete response or partial response, as assessed by independent central review(ICR) based on RECIST 1.1.
Outcome measures
| Measure |
T-DXd Arm
n=72 Participants
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
ICR-assessed ORR (Objective Response Rate)
|
56.9 Percentage of participants
Interval 44.7 to 68.6
|
SECONDARY outcome
Timeframe: Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months. (from date of enrolment to final analysis data cut-off)Population: Full analysis set
Confirmed ORR is defined as the percentage of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1
Outcome measures
| Measure |
T-DXd Arm
n=72 Participants
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
Investigator-assessed ORR (Objective Response Rate)
|
59.7 Percentage of participants
Interval 47.5 to 71.1
|
SECONDARY outcome
Timeframe: Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months.Population: Full analysis set (patients with confirmed objective response included in the analysis)
DoR is time from the initial confirmed response (CR or PR) until documented tumour progression or death from any cause.
Outcome measures
| Measure |
T-DXd Arm
n=41 Participants
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
ICR-assessed DoR (Duration of Response)
|
11.6 Months
Interval 5.8 to
The data are unavailable because a substantial proportion of participants were censored (18/41, 43.9%), which may indicate that there were too few events to allow for estimation.
|
SECONDARY outcome
Timeframe: Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months.Population: Full analysis set (patients with confirmed objective response included in the analysis)
DoR is time from the initial confirmed response (CR or PR) until documented tumour progression or death from any cause.
Outcome measures
| Measure |
T-DXd Arm
n=43 Participants
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
Investigator-assessed DoR (Duration of Response)
|
9.4 Months
Interval 7.2 to 13.5
|
SECONDARY outcome
Timeframe: Tumour assessments (per RECIST 1.1) every 6 weeks for the first 48 weeks relative to the date of enrolment and then every 9 weeks thereafter. Assessed up to 28 months.Population: Full analysis set
DCR is the percentage of participants who achieved confirmed CR, PR, or SD during study intervention.
Outcome measures
| Measure |
T-DXd Arm
n=72 Participants
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
ICR-assessed and Investigator-assessed DCR (Disease Control Rate)
ICR-assessed
|
91.7 Percentage of participants
Interval 82.7 to 96.9
|
|
ICR-assessed and Investigator-assessed DCR (Disease Control Rate)
Investigator-assessed
|
93.1 Percentage of participants
Interval 84.5 to 97.7
|
SECONDARY outcome
Timeframe: Tumour assessments every 6 weeks after enrolment for the first 48 weeks and then every 9 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Assessed up to 28 months.Population: Full analysis set
PFS is the time from date of enrolment until first objective radiographic tumour progression or death from any cause.
Outcome measures
| Measure |
T-DXd Arm
n=72 Participants
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
ICR-assessed and Investigator-assessed PFS (Progression-free Survival)
ICR-assessed
|
9.9 Months
Interval 7.1 to 16.5
|
|
ICR-assessed and Investigator-assessed PFS (Progression-free Survival)
Investigator-assessed
|
9.7 Months
Interval 8.1 to 13.4
|
SECONDARY outcome
Timeframe: From date of enrolment until death due to any cause. Assessed up to 28 months.Population: Full analysis set
OS is the time from date of enrolment until death from any cause.
Outcome measures
| Measure |
T-DXd Arm
n=72 Participants
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
OS (Overall Survival)
|
21.0 Months
Interval 17.5 to
NA - not calculated as an insufficient number of events for the upper limits of the 95% confidence interval
|
SECONDARY outcome
Timeframe: Tumour assessments every 6 weeks after enrolment for the first 48 weeks and then every 9 weeks thereafter until date of RECIST 1.1 defined CNS tumour progressive disease or death in the absence of CNS progression. Assessed up to 28 months.Population: Full analysis set
CNS-PFS is the time from date of enrolment until CNS tumour progression per RECIST 1.1 as assessed by ICR or death due to any cause in the absence of CNS progression.
Outcome measures
| Measure |
T-DXd Arm
n=72 Participants
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
ICR-assessed CNS-PFS (Central Nervous System Progression-free Survival)
|
15.5 Months
Interval 9.9 to
NA - not calculated as an insufficient number of events for the upper limits of the 95% confidence interval
|
SECONDARY outcome
Timeframe: 24 weeks from day 1 of cycle 1 to cycle 8Population: PK analysis set
Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd.
Outcome measures
| Measure |
T-DXd Arm
n=72 Participants
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
Serum Concentrations of T-DXd
Cycle 1 Pre-dose
|
NA μg/mL
Geometric Coefficient of Variation NA
NA - Not calculated, estimate cannot be calculated as too many values were below the lower limit of quantification.
|
|
Serum Concentrations of T-DXd
Cycle 1 5 hour post-dose
|
106.1 μg/mL
Geometric Coefficient of Variation 77.96
|
|
Serum Concentrations of T-DXd
Cycle 2 Pre-dose
|
3.072 μg/mL
Geometric Coefficient of Variation 121.6
|
|
Serum Concentrations of T-DXd
Cycle 2 End of infusion
|
117.4 μg/mL
Geometric Coefficient of Variation 18.79
|
|
Serum Concentrations of T-DXd
Cycle 3 Pre-dose
|
5.262 μg/mL
Geometric Coefficient of Variation 111.2
|
|
Serum Concentrations of T-DXd
Cycle 3 End of infusion
|
120.9 μg/mL
Geometric Coefficient of Variation 17.04
|
|
Serum Concentrations of T-DXd
Cycle 4 Pre-dose
|
8.014 μg/mL
Geometric Coefficient of Variation 60.69
|
|
Serum Concentrations of T-DXd
Cycle 4 End of infusion
|
118.4 μg/mL
Geometric Coefficient of Variation 18.44
|
|
Serum Concentrations of T-DXd
Cycle 6 Pre-dose
|
9.024 μg/mL
Geometric Coefficient of Variation 67.20
|
|
Serum Concentrations of T-DXd
Cycle 8 Pre-dose
|
10.39 μg/mL
Geometric Coefficient of Variation 65.12
|
|
Serum Concentrations of T-DXd
Cycle 1 End of infusion
|
120.5 μg/mL
Geometric Coefficient of Variation 18.33
|
SECONDARY outcome
Timeframe: 24 weeks from day 1 of cycle 1 to cycle 8Population: PK analysis set
Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for total anti-HER2 antibody.
Outcome measures
| Measure |
T-DXd Arm
n=72 Participants
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
Serum Concentrations of Total Anti-HER2 Antibody
Cycle 1 Pre-dose
|
NA ug/mL
Geometric Coefficient of Variation NA
NA - Not calculated, estimate cannot be calculated as too many values were below the lower limit of quantification.
|
|
Serum Concentrations of Total Anti-HER2 Antibody
Cycle 1 End of infusion
|
127.5 ug/mL
Geometric Coefficient of Variation 21.93
|
|
Serum Concentrations of Total Anti-HER2 Antibody
Cycle 1 5 hour post-dose
|
118.0 ug/mL
Geometric Coefficient of Variation 18.85
|
|
Serum Concentrations of Total Anti-HER2 Antibody
Cycle 2 Pre-dose
|
2.866 ug/mL
Geometric Coefficient of Variation 148.7
|
|
Serum Concentrations of Total Anti-HER2 Antibody
Cycle 2 End of infusion
|
120.1 ug/mL
Geometric Coefficient of Variation 39.66
|
|
Serum Concentrations of Total Anti-HER2 Antibody
Cycle 3 Pre-dose
|
4.582 ug/mL
Geometric Coefficient of Variation 126.4
|
|
Serum Concentrations of Total Anti-HER2 Antibody
Cycle 3 End of infusion
|
125.9 ug/mL
Geometric Coefficient of Variation 16.87
|
|
Serum Concentrations of Total Anti-HER2 Antibody
Cycle 4 Pre-dose
|
6.974 ug/mL
Geometric Coefficient of Variation 84.38
|
|
Serum Concentrations of Total Anti-HER2 Antibody
Cycle 4 End of infusion
|
121.3 ug/mL
Geometric Coefficient of Variation 16.80
|
|
Serum Concentrations of Total Anti-HER2 Antibody
Cycle 6 Pre-dose
|
8.049 ug/mL
Geometric Coefficient of Variation 94.39
|
|
Serum Concentrations of Total Anti-HER2 Antibody
Cycle 8 Pre-dose
|
9.579 ug/mL
Geometric Coefficient of Variation 83.64
|
SECONDARY outcome
Timeframe: 24 weeks from day 1 of cycle 1 to cycle 8Population: PK analysis set
Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for DXd.
Outcome measures
| Measure |
T-DXd Arm
n=72 Participants
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
Serum Concentrations of DXd
Cycle 1 Pre-dose
|
NA ng/mL
Geometric Coefficient of Variation NA
NA - Not calculated, estimate cannot be calculated as too many values were below the lower limit of quantification.
|
|
Serum Concentrations of DXd
Cycle 1 End of infusion
|
5.384 ng/mL
Geometric Coefficient of Variation 47.55
|
|
Serum Concentrations of DXd
Cycle 1 5 hour post-dose
|
12.90 ng/mL
Geometric Coefficient of Variation 69.38
|
|
Serum Concentrations of DXd
Cycle 2 Pre-dose
|
0.1751 ng/mL
Geometric Coefficient of Variation 119.4
|
|
Serum Concentrations of DXd
Cycle 2 End of infusion
|
2.657 ng/mL
Geometric Coefficient of Variation 70.96
|
|
Serum Concentrations of DXd
Cycle 3 Pre-dose
|
0.2423 ng/mL
Geometric Coefficient of Variation 110.6
|
|
Serum Concentrations of DXd
Cycle 3 End of infusion
|
2.310 ng/mL
Geometric Coefficient of Variation 50.12
|
|
Serum Concentrations of DXd
Cycle 4 Pre-dose
|
0.3226 ng/mL
Geometric Coefficient of Variation 53.71
|
|
Serum Concentrations of DXd
Cycle 4 End of infusion
|
2.139 ng/mL
Geometric Coefficient of Variation 51.35
|
|
Serum Concentrations of DXd
Cycle 6 Pre-dose
|
0.3286 ng/mL
Geometric Coefficient of Variation 58.35
|
|
Serum Concentrations of DXd
Cycle 8 Pre-dose
|
0.3749 ng/mL
Geometric Coefficient of Variation 54.09
|
Adverse Events
T-DXd
Serious events: 41 serious events
Other events: 72 other events
Deaths: 41 deaths
Serious adverse events
| Measure |
T-DXd
n=72 participants at risk
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
Gastrointestinal disorders
Gastritis
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
4/72 • Number of events 5 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
General disorders
Asthenia
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
General disorders
Death
|
2.8%
2/72 • Number of events 2 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Blood and lymphatic system disorders
Anaemia
|
2.8%
2/72 • Number of events 2 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Infections and infestations
Covid-19
|
6.9%
5/72 • Number of events 5 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Infections and infestations
Covid-19 pneumonia
|
5.6%
4/72 • Number of events 4 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Infections and infestations
Herpes zoster
|
2.8%
2/72 • Number of events 2 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Infections and infestations
Pneumonia
|
2.8%
2/72 • Number of events 2 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Infections and infestations
Pneumonia bacterial
|
2.8%
2/72 • Number of events 2 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Platelet count decreased
|
8.3%
6/72 • Number of events 7 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Nervous system disorders
Brain oedema
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Nervous system disorders
Seizure
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
6.9%
5/72 • Number of events 5 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.9%
5/72 • Number of events 5 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Vascular disorders
Venous thrombosis limb
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
1.4%
1/72 • Number of events 1 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
Other adverse events
| Measure |
T-DXd
n=72 participants at risk
Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
5.6%
4/72 • Number of events 9 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Blood bilirubin increased
|
13.9%
10/72 • Number of events 21 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
36/72 • Number of events 78 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Alpha hydroxybutyrate dehydrogenase increased
|
6.9%
5/72 • Number of events 9 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Aspartate aminotransferase increased
|
59.7%
43/72 • Number of events 112 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Bile acids increased
|
6.9%
5/72 • Number of events 11 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Bilirubin conjugated increased
|
9.7%
7/72 • Number of events 15 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Blood alkaline phosphatase increased
|
19.4%
14/72 • Number of events 31 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Gastrointestinal disorders
Nausea
|
59.7%
43/72 • Number of events 155 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Gastrointestinal disorders
Stomatitis
|
6.9%
5/72 • Number of events 5 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Gastrointestinal disorders
Vomiting
|
36.1%
26/72 • Number of events 61 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
General disorders
Asthenia
|
16.7%
12/72 • Number of events 29 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
General disorders
Fatigue
|
12.5%
9/72 • Number of events 14 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
General disorders
Influenza like illness
|
6.9%
5/72 • Number of events 6 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
General disorders
Malaise
|
11.1%
8/72 • Number of events 11 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
General disorders
Non-cardiac chest pain
|
6.9%
5/72 • Number of events 10 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Blood and lymphatic system disorders
Anaemia
|
63.9%
46/72 • Number of events 115 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
General disorders
Oedema peripheral
|
6.9%
5/72 • Number of events 5 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
General disorders
Pyrexia
|
8.3%
6/72 • Number of events 9 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Infections and infestations
Covid-19
|
36.1%
26/72 • Number of events 29 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Infections and infestations
Covid-19 pneumonia
|
6.9%
5/72 • Number of events 5 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Infections and infestations
Pneumonia
|
15.3%
11/72 • Number of events 11 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
5/72 • Number of events 6 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Blood bilirubin unconjugated increased
|
5.6%
4/72 • Number of events 13 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Blood creatinine increased
|
6.9%
5/72 • Number of events 6 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Gastrointestinal disorders
Abdominal distension
|
13.9%
10/72 • Number of events 21 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Blood lactate dehydrogenase increased
|
13.9%
10/72 • Number of events 18 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Blood urea increased
|
5.6%
4/72 • Number of events 4 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Ejection fraction decreased
|
5.6%
4/72 • Number of events 4 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Gamma-glutamyltransferase increased
|
30.6%
22/72 • Number of events 31 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Lymphocyte count decreased
|
22.2%
16/72 • Number of events 43 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Neutrophil count decreased
|
65.3%
47/72 • Number of events 233 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Platelet count decreased
|
66.7%
48/72 • Number of events 133 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Weight decreased
|
18.1%
13/72 • Number of events 18 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
Weight increased
|
6.9%
5/72 • Number of events 6 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Investigations
White blood cell count decreased
|
66.7%
48/72 • Number of events 267 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
8/72 • Number of events 15 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
43.1%
31/72 • Number of events 61 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
12/72 • Number of events 16 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
9.7%
7/72 • Number of events 20 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
13.9%
10/72 • Number of events 26 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
34.7%
25/72 • Number of events 61 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
18/72 • Number of events 39 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
6.9%
5/72 • Number of events 5 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
29.2%
21/72 • Number of events 47 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
23.6%
17/72 • Number of events 24 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.9%
5/72 • Number of events 7 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
8.3%
6/72 • Number of events 11 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Psychiatric disorders
Insomnia
|
12.5%
9/72 • Number of events 14 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
14/72 • Number of events 16 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
4/72 • Number of events 4 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Gastrointestinal disorders
Constipation
|
23.6%
17/72 • Number of events 28 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.6%
4/72 • Number of events 4 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.9%
10/72 • Number of events 10 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
4/72 • Number of events 4 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.9%
5/72 • Number of events 6 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Vascular disorders
Hypertension
|
11.1%
8/72 • Number of events 22 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
|
Gastrointestinal disorders
Diarrhoea
|
13.9%
10/72 • Number of events 12 • From date of informed consent throughout the treatment period and the safety follow-up period (until 40 (+7) days after the last dose of study treatment).
|
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
- Publication restrictions are in place