Trial Outcomes & Findings for A Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC (NCT NCT04606771)
NCT ID: NCT04606771
Last Updated: 2026-02-27
Results Overview
Percentage of evaluable patients with an Investigator-assessed visit response of complete response (CR) or partial response (PR). CR defined as disappearance of all target and non-target lesions and no new lesions. PR defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesions. Overall Response (OR) = CR + PR.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Tumour assessments every 6 weeks from randomisation up to 24 weeks, then every 8 weeks until objective disease progression (maximum of approximately 25 months)
Results posted on
2026-02-27
Participant Flow
Participant milestones
| Measure |
Savolitinib Plus Osimertinib
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
16
|
Reasons for withdrawal
| Measure |
Savolitinib Plus Osimertinib
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
Overall Study
Patients ongoing study at data cut-off
|
9
|
9
|
|
Overall Study
Death
|
5
|
6
|
|
Overall Study
Wrong randomisation
|
0
|
1
|
Baseline Characteristics
A Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC
Baseline characteristics by cohort
| Measure |
Savolitinib Plus Osimertinib
n=14 Participants
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
n=16 Participants
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.2 Years
STANDARD_DEVIATION 11.42 • n=24 Participants
|
62.5 Years
STANDARD_DEVIATION 10.02 • n=20 Participants
|
59.6 Years
STANDARD_DEVIATION 10.98 • n=40 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=24 Participants
|
9 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=24 Participants
|
7 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=24 Participants
|
15 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=24 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
1 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Tumour assessments every 6 weeks from randomisation up to 24 weeks, then every 8 weeks until objective disease progression (maximum of approximately 25 months)Percentage of evaluable patients with an Investigator-assessed visit response of complete response (CR) or partial response (PR). CR defined as disappearance of all target and non-target lesions and no new lesions. PR defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesions. Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Savolitinib Plus Osimertinib
n=14 Participants
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
n=16 Participants
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
Objective Response Rate (ORR)
|
57.1 Percentage of participants
Interval 28.86 to 82.34
|
12.5 Percentage of participants
Interval 1.55 to 38.35
|
SECONDARY outcome
Timeframe: Tumour assessments every 6 weeks from randomisation up to 24 weeks, then every 8 weeks until objective disease progression (maximum of approximately 25 months)PFS is defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy prior to progression. Progression (i.e., PD) is defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters.
Outcome measures
| Measure |
Savolitinib Plus Osimertinib
n=14 Participants
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
n=16 Participants
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
Progression-free Survival (PFS)
|
7.36 Months
Interval 5.55 to
NA - Not calculated, estimates cannot be calculated due to too few events
|
1.64 Months
Interval 1.28 to 4.07
|
SECONDARY outcome
Timeframe: Tumour assessments every 6 weeks from randomisation up to 24 weeks, then every 8 weeks until objective disease progression (maximum of approximately 25 months)DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by the investigator or death in the absence of disease progression.
Outcome measures
| Measure |
Savolitinib Plus Osimertinib
n=8 Participants
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
n=2 Participants
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
Duration of Response (DoR)
|
30.57 Weeks
Interval 18.86 to
NA - Not calculated, estimates cannot be calculated due to too few events
|
NA Weeks
Interval 12.43 to
NA - Not calculated, estimates cannot be calculated due to too few events
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks.Population: Patients with either a tumour size recorded at 12 weeks or enough information to impute a value.
TSA is defined as the percentage change from baseline in TLs at 12 weeks per RECIST 1.1 as assessed by the investigator.
Outcome measures
| Measure |
Savolitinib Plus Osimertinib
n=12 Participants
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
n=13 Participants
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
Tumour Size Assessment (TSA)
|
-35.0 Percentage change
Standard Deviation 29.62
|
8.5 Percentage change
Standard Deviation 38.95
|
SECONDARY outcome
Timeframe: From the date of randomisation until death due to any cause, assessed up to the data cut-off date (21 December 2022) (maximum of approximately 25 months)OS is defined as time from randomisation until the date of death due to any cause.
Outcome measures
| Measure |
Savolitinib Plus Osimertinib
n=14 Participants
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
n=16 Participants
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Interval 9.56 to
NA - Not calculated, estimates cannot be calculated due to too few events
|
13.37 Months
Interval 7.82 to
NA - Not calculated, estimates cannot be calculated due to too few events
|
SECONDARY outcome
Timeframe: 6-weeks after therapy initiation.To determine the prevalence of ctDNA clearance after savolitinib plus osimertinib or savolitinib plus placebo treatment in this patient population
Outcome measures
| Measure |
Savolitinib Plus Osimertinib
n=3 Participants
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
n=8 Participants
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
Total Clearance in EGFR Mutations at 6-weeks After Therapy Initiation (Percentage Change From Baseline in EGFR Mutation Allele Frequencies).
|
-93.6 Allele Frequency
Standard Deviation 11.03
|
-62.7 Allele Frequency
Standard Deviation 48.73
|
SECONDARY outcome
Timeframe: 6-weeks after therapy initiation.To determine the prevalence of ctDNA clearance after savolitinib plus osimertinib or savolitinib plus placebo treatment in this patient population
Outcome measures
| Measure |
Savolitinib Plus Osimertinib
n=3 Participants
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
n=8 Participants
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
Total Clearance in EGFR Mutations at 6-weeks After Therapy Initiation (Absolute Change From Baseline in EGFR Mutation Allele Frequencies).
|
-17.4 Allele Frequency
Standard Deviation 17.59
|
-2.9 Allele Frequency
Standard Deviation 2.93
|
SECONDARY outcome
Timeframe: C3h Cycle 2 Day 1/C3h Cycle 1 Day 1; Cpre-dose Cycle 3 Day 1/Cpre-dose Cycle 2 Day 1; Cpre-dose Cycle 6 Day 1/Cpre-dose Cycle 2 Day 1; Cpre-dose Cycle 11 Day 1/Cpre-dose Cycle 2 Day 1. (Each Cycle is 28 days)Population: Geometric mean ratios provided for three different visit combinations
The time dependency of the PK on multiple dosing is assessed by the ratio of mean concentrations at the timepoints identified in column one. For example, the Geometric mean ratio for "C3h Cycle2 Day 1 / C3h Cycle 1 Day 1" periods is the geometric mean value for C3h Cycle 2 Day 1 (Stage 2) divided by the geometric mean value for C3h Cycle 1 Day 1 (Stage 1). Because the measurement is a ratio of values, no measures of central tendency are appropriate.
Outcome measures
| Measure |
Savolitinib Plus Osimertinib
n=30 Participants
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
n=14 Participants
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
PK Concentration Ratios on Multiple Dosing
C3h Cycle 2 Day 1 / C3h Cycle 1 Day 1
|
0.8812 Geometric mean ratio
|
1.081 Geometric mean ratio
|
|
PK Concentration Ratios on Multiple Dosing
Cpre-dose Cycle 3 Day 1 / Cpre-dose Cycle 2 Day 1
|
0.8650 Geometric mean ratio
|
1.032 Geometric mean ratio
|
|
PK Concentration Ratios on Multiple Dosing
Cpre-dose Cycle 6 Day 1 / Cpre-dose Cycle 2 Day 1
|
0.6352 Geometric mean ratio
|
1.068 Geometric mean ratio
|
SECONDARY outcome
Timeframe: Cycle 3, Day 1: Pre-dose and 1, 3, 4, and 6 hours post-dosePopulation: All patients with PK data are analysed for savolitinib, osimertinib and their metabolites
Area under the plasma concentration-time curve at steady state
Outcome measures
| Measure |
Savolitinib Plus Osimertinib
n=13 Participants
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
n=5 Participants
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
AUCss of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
M3
|
966.7 h*ng/mL
Geometric Coefficient of Variation 49.07
|
1348 h*ng/mL
Geometric Coefficient of Variation 42.37
|
|
AUCss of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
Osimertinib
|
12910 h*ng/mL
Geometric Coefficient of Variation 50.80
|
—
|
|
AUCss of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
AZ5104
|
1086 h*ng/mL
Geometric Coefficient of Variation 70.80
|
—
|
|
AUCss of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
Savolitinib
|
7875 h*ng/mL
Geometric Coefficient of Variation 37.54
|
11890 h*ng/mL
Geometric Coefficient of Variation 37.56
|
|
AUCss of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
M2
|
2630 h*ng/mL
Geometric Coefficient of Variation 48.80
|
3516 h*ng/mL
Geometric Coefficient of Variation 44.43
|
SECONDARY outcome
Timeframe: Cycle 3, Day 1: Pre-dose and 1, 3, 4, and 6 hours post-dosePopulation: All patients with PK data are analysed for savolitinib, osimertinib and their metabolites
Maximum steady state plasma concentration
Outcome measures
| Measure |
Savolitinib Plus Osimertinib
n=13 Participants
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
n=7 Participants
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
Cssmax of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
Savolitinib
|
1282 ng/mL
Geometric Coefficient of Variation 35.65
|
2058 ng/mL
Geometric Coefficient of Variation 32.00
|
|
Cssmax of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
M2
|
351.0 ng/mL
Geometric Coefficient of Variation 39.91
|
581.5 ng/mL
Geometric Coefficient of Variation 21.19
|
|
Cssmax of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
M3
|
129.0 ng/mL
Geometric Coefficient of Variation 34.90
|
213.9 ng/mL
Geometric Coefficient of Variation 36.08
|
|
Cssmax of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
Osimertinib
|
678.3 ng/mL
Geometric Coefficient of Variation 50.80
|
—
|
|
Cssmax of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
AZ5104
|
51.23 ng/mL
Geometric Coefficient of Variation 70.14
|
—
|
SECONDARY outcome
Timeframe: Cycle 3, Day 1: Pre-dose and 1, 3, 4, and 6 hours post-dosePopulation: All patients with PK data are analysed for savolitinib, osimertinib and their metabolites
Time to maximum plasma concentration at steady state
Outcome measures
| Measure |
Savolitinib Plus Osimertinib
n=13 Participants
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
n=7 Participants
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
Tssmax of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
Savolitinib
|
3.00 h
Interval 1.0 to 5.62
|
3.00 h
Interval 0.95 to 6.0
|
|
Tssmax of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
M2
|
3.00 h
Interval 1.0 to 5.62
|
1.05 h
Interval 0.95 to 6.0
|
|
Tssmax of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
M3
|
3.00 h
Interval 0.92 to 5.78
|
1.05 h
Interval 0.95 to 6.0
|
|
Tssmax of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
Osimertinib
|
4.00 h
Interval 3.0 to 6.0
|
—
|
|
Tssmax of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
AZ5104
|
4.00 h
Interval 0.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: Cycle 3, Day 1 (Each Cycle is 28 days)Population: All patients with PK data are analysed for savolitinib, osimertinib and their metabolites
To evaluate the PK of savolitinib and osimertinib.
Outcome measures
| Measure |
Savolitinib Plus Osimertinib
n=13 Participants
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
n=5 Participants
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
CLss/F of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
Savolitinib
|
38.10 L/h
Geometric Coefficient of Variation 37.54
|
25.23 L/h
Geometric Coefficient of Variation 37.56
|
|
CLss/F of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
M2
|
114.1 L/h
Geometric Coefficient of Variation 48.80
|
85.32 L/h
Geometric Coefficient of Variation 44.43
|
|
CLss/F of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
M3
|
310.3 L/h
Geometric Coefficient of Variation 49.07
|
222.5 L/h
Geometric Coefficient of Variation 42.37
|
|
CLss/F of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
Osimertinib
|
0.01241 L/h
Geometric Coefficient of Variation 50.80
|
—
|
|
CLss/F of Savolitinib, Osimertinib and Their Metabolites, (M2 and M3 for Savolitinib; AZ5104 for Osimertinib)
AZ5104
|
0.1475 L/h
Geometric Coefficient of Variation 70.80
|
—
|
Adverse Events
Savolitinib Plus Osimertinib
Serious events: 4 serious events
Other events: 13 other events
Deaths: 5 deaths
Savolitinib Plus Placebo
Serious events: 3 serious events
Other events: 16 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Savolitinib Plus Osimertinib
n=14 participants at risk
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
n=16 participants at risk
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
General disorders
Pyrexia
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
18.8%
3/16 • Number of events 3 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Infections and infestations
Septic shock
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Investigations
Hepatic enzyme increased
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Renal and urinary disorders
Haematuria
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Vascular disorders
Deep vein thrombosis
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
Other adverse events
| Measure |
Savolitinib Plus Osimertinib
n=14 participants at risk
Savolitinib 300 mg oral QD
Osimertinib 80 mg oral QD
|
Savolitinib Plus Placebo
n=16 participants at risk
Savolitinib 300 mg oral QD
Placebo to Osimertinib 80mg oral QD
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
7/14 • Number of events 7 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
18.8%
3/16 • Number of events 3 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Gastrointestinal disorders
Oesophagitis
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
2/14 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Gastrointestinal disorders
Vomiting
|
21.4%
3/14 • Number of events 3 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
31.2%
5/16 • Number of events 6 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
General disorders
Asthenia
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
General disorders
Fatigue
|
21.4%
3/14 • Number of events 3 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
General disorders
Oedema
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
2/14 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
12.5%
2/16 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
General disorders
Oedema peripheral
|
35.7%
5/14 • Number of events 6 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
25.0%
4/16 • Number of events 4 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
General disorders
Pyrexia
|
14.3%
2/14 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Infections and infestations
Covid-19
|
14.3%
2/14 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Infections and infestations
Cellulitis
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Infections and infestations
Paronychia
|
14.3%
2/14 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Infections and infestations
Viral rash
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Investigations
Amylase increased
|
14.3%
2/14 • Number of events 3 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
25.0%
4/16 • Number of events 5 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.1%
1/14 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Investigations
Blood creatinine increased
|
14.3%
2/14 • Number of events 3 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Investigations
Lipase increased
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Investigations
Neutrophil count decreased
|
7.1%
1/14 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Investigations
Transaminases increased
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
25.0%
4/16 • Number of events 4 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
21.4%
3/14 • Number of events 4 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
12.5%
2/16 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.3%
2/14 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
2/14 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
12.5%
2/16 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
2/14 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
12.5%
2/16 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
18.8%
3/16 • Number of events 3 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.1%
1/14 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
12.5%
2/16 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Nervous system disorders
Headache
|
28.6%
4/14 • Number of events 5 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Psychiatric disorders
Delirium
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
18.8%
3/16 • Number of events 3 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Renal and urinary disorders
Dysuria
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
18.8%
3/16 • Number of events 3 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
18.8%
3/16 • Number of events 3 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
12.5%
2/16 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
12.5%
2/16 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
21.4%
3/14 • Number of events 3 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
2/14 • Number of events 2 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Vascular disorders
Superior vena cava occlusion
|
7.1%
1/14 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
0.00%
0/16 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
6.2%
1/16 • Number of events 1 • Collected throughout the study, from date of informed consent until 28 days after the last dose of study treatment (or end of follow up period). All-cause mortality (death due to any cause): from randomisation up to data cut-off date (21 Dec 2022). Maximum timeframe of approximately 24.4 months.
|
Additional Information
Global Clinical Lead
AstraZeneca Clinical Study Information Center
Phone: 1-877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place