Trial Outcomes & Findings for Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA) (NCT NCT03830866)
NCT ID: NCT03830866
Last Updated: 2024-07-26
Results Overview
PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
770 participants
Primary outcome timeframe
Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 months
Results posted on
2024-07-26
Participant Flow
Participant milestones
| Measure |
Durvalumab + SoC CCRT
Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
Placebo + SoC CCRT
Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
|---|---|---|
|
Overall Study
STARTED
|
385
|
385
|
|
Overall Study
COMPLETED
|
268
|
249
|
|
Overall Study
NOT COMPLETED
|
117
|
136
|
Reasons for withdrawal
| Measure |
Durvalumab + SoC CCRT
Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
Placebo + SoC CCRT
Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
|---|---|---|
|
Overall Study
Death
|
90
|
111
|
|
Overall Study
Lost to Follow-up
|
7
|
7
|
|
Overall Study
Withdrawal by Subject
|
19
|
16
|
|
Overall Study
No longer eligible due to additional cancer diagnosis
|
0
|
1
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
Baseline characteristics by cohort
| Measure |
Durvalumab + SoC CCRT
n=385 Participants
Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
Placebo + SoC CCRT
n=385 Participants
Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
Total
n=770 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.6 Years
STANDARD_DEVIATION 11.74 • n=99 Participants
|
48.8 Years
STANDARD_DEVIATION 11.67 • n=107 Participants
|
49.2 Years
STANDARD_DEVIATION 11.70 • n=206 Participants
|
|
Sex: Female, Male
Female
|
385 Participants
n=99 Participants
|
385 Participants
n=107 Participants
|
770 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
130 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
255 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
152 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
300 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
47 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
46 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 monthsPopulation: Full Analysis Set
PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression
Outcome measures
| Measure |
Durvalumab + SoC CCRT
n=385 Participants
Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
Placebo + SoC CCRT
n=385 Participants
Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
|---|---|---|
|
Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression
|
NA Months
NA - Not calculated, estimates cannot be calculated due to too few events
|
NA Months
NA - Not calculated, estimates cannot be calculated due to too few events
|
SECONDARY outcome
Timeframe: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 monthsPopulation: PD-L1 Analysis Set
PFS defined as time from date of randomisation until date of tumour progression or death by any cause, regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression
Outcome measures
| Measure |
Durvalumab + SoC CCRT
n=385 Participants
Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
Placebo + SoC CCRT
n=385 Participants
Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
|---|---|---|
|
Progression-free Survival (PFS) Based on the Investigator Assessment According to RECIST 1.1 or Histopathologic Confirmation of Local Tumour Progression, PD-L1 Expression >= 1%
|
NA Months
NA - Not calculated, estimates cannot be calculated due to too few events
|
NA Months
Interval 26.9 to
NA - Not calculated, estimates cannot be calculated due to too few events
|
SECONDARY outcome
Timeframe: Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (3rd July 2023), assessed up to a maximum of 51.7 monthsPopulation: Full Analysis Set
Number of Participants with Overall Survival (OS) where OS was defined as the time from the date of randomisation until death by any cause
Outcome measures
| Measure |
Durvalumab + SoC CCRT
n=385 Participants
Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
Placebo + SoC CCRT
n=385 Participants
Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
|---|---|---|
|
Overall Survival (Count)
Died
|
91 Participants
|
112 Participants
|
|
Overall Survival (Count)
Censored (includes subjects who withdrew consent and subjects who were lost to follow up)
|
294 Participants
|
273 Participants
|
SECONDARY outcome
Timeframe: Time from date of randomisation until date of death by any cause, assessed up to the data cut-off date (3rd July 2023), assessed up to a maximum of 51.7 monthsPopulation: Full Analysis Set
Time from the date of randomisation until death by any cause
Outcome measures
| Measure |
Durvalumab + SoC CCRT
n=385 Participants
Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
Placebo + SoC CCRT
n=385 Participants
Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
|---|---|---|
|
Overall Survival (Duration)
|
NA Months
NA - Not calculated, estimates cannot be calculated due to too few events
|
NA Months
NA - Not calculated, estimates cannot be calculated due to too few events
|
SECONDARY outcome
Timeframe: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 monthsPopulation: Full analysis set
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 lesion
Outcome measures
| Measure |
Durvalumab + SoC CCRT
n=385 Participants
Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
Placebo + SoC CCRT
n=385 Participants
Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
|---|---|---|
|
Objective Response Rate (ORR)
|
82.6 Percentage of Participants
|
80.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 monthsPopulation: Full analysis set
Percentage of evaluable patients with an overall visit response of Complete Response (disappearance of all target and non-target lesions)
Outcome measures
| Measure |
Durvalumab + SoC CCRT
n=385 Participants
Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
Placebo + SoC CCRT
n=385 Participants
Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
|---|---|---|
|
Complete Response Rate
|
42.9 Percentage of Participants
|
40.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Tumor assessments start 20 weeks after randomisation then every 12 weeks up to 164 weeks, then every 24 weeks until date of RECIST1.1 defined radiological progression. Assessed up to date of DCO (20-Jan-2022) to a maximum of 32.6 monthsPopulation: Full Analysis Set
Time from date of first documented CR until date of documented progression or death in the absence of progression. For patients who did not progress their DoR was their Progression-free survival censoring time
Outcome measures
| Measure |
Durvalumab + SoC CCRT
n=385 Participants
Durvalumab 1500mg IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
Placebo + SoC CCRT
n=385 Participants
Placebo IV infusion every 4 weeks plus Standard of Care (SoC) concurrent chemoradiotherapy (CCRT) (chemotherapy for 5 weeks plus external beam radiotherapy and brachytherapy)
|
|---|---|---|
|
Duration of Response (DoR) in Patients With Complete Response (CR)
|
NA Months
NA - Not calculated, estimates cannot be calculated due to too few events
|
NA Months
NA - Not calculated, estimates cannot be calculated due to too few events
|
Adverse Events
Durva + SoC CCRT
Serious events: 113 serious events
Other events: 373 other events
Deaths: 91 deaths
Placebo + SoC CCRT
Serious events: 90 serious events
Other events: 368 other events
Deaths: 112 deaths
Serious adverse events
| Measure |
Durva + SoC CCRT
n=385 participants at risk
Description (Arm-group)
|
Placebo + SoC CCRT
n=384 participants at risk
Description (Arm-group)
|
|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
Aspartate aminotransferase increased
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
Blood creatinine increased
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.52%
2/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
C-reactive protein increased
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
Electrocardiogram q wave abnormal
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
Full blood count decreased
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.52%
2/385 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Cardiac disorders
Acute myocardial infarction
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Pseudomembranous colitis
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.52%
2/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory pseudotumour
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Nervous system disorders
Cerebral infarction
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Nervous system disorders
Cerebrovascular accident
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Pyelonephritis
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.52%
2/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Endocrine disorders
Adrenal insufficiency
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Nervous system disorders
Headache
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.52%
2/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Nervous system disorders
Seizure
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Nervous system disorders
Transient ischaemic attack
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Psychiatric disorders
Acute psychosis
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Psychiatric disorders
Anxiety
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Endocrine disorders
Endocrine disorder
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
6/385 • Number of events 6 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.78%
3/384 • Number of events 3 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Renal and urinary disorders
Haematuria
|
0.52%
2/385 • Number of events 5 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Renal and urinary disorders
Hydronephrosis
|
0.78%
3/385 • Number of events 3 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Renal and urinary disorders
Renal failure
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Renal and urinary disorders
Ureteric fistula
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.78%
3/385 • Number of events 3 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Renal and urinary disorders
Urogenital fistula
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Reproductive system and breast disorders
Cervix haemorrhage uterine
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
1.0%
4/385 • Number of events 4 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.52%
2/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.8%
7/385 • Number of events 8 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
1.3%
5/384 • Number of events 5 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.52%
2/385 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
1.0%
4/384 • Number of events 4 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.78%
3/385 • Number of events 4 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.52%
2/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Vascular disorders
Accelerated hypertension
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Vascular disorders
Embolism
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Eye disorders
Cataract
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Vascular disorders
Hypovolaemic shock
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.52%
2/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Blood and lymphatic system disorders
Anaemia
|
5.2%
20/385 • Number of events 20 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
5.2%
20/384 • Number of events 20 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
6/385 • Number of events 7 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.52%
2/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Anorectal disorder
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Colitis
|
0.78%
3/385 • Number of events 3 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
4/385 • Number of events 4 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.52%
2/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Enterocolitis
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.52%
2/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Gastritis
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Ileus
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.52%
2/385 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Nausea
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.3%
5/385 • Number of events 5 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Pancreatitis
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Proctitis
|
0.52%
2/385 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Rectal perforation
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.52%
2/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Vomiting
|
0.52%
2/385 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
General disorders
Asthenia
|
0.52%
2/385 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
General disorders
Fatigue
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
General disorders
Generalised oedema
|
0.26%
1/385 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
General disorders
Oedema
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
General disorders
Oedema peripheral
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
General disorders
Pyrexia
|
0.78%
3/385 • Number of events 4 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Hepatobiliary disorders
Bile duct stone
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Hepatobiliary disorders
Hepatitis
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Appendicitis
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Atypical pneumonia
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Covid-19
|
0.78%
3/385 • Number of events 3 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Cellulitis
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Cystitis
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Device related infection
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Endometritis
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Gastroenteritis
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Gingivitis
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Hepatitis c
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Infected lymphocele
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Peritonitis
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Pneumonia
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
1.0%
4/384 • Number of events 4 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
Neutrophil count decreased
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.52%
2/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
Platelet count decreased
|
0.78%
3/385 • Number of events 3 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.78%
3/384 • Number of events 4 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
White blood cell count decreased
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Metabolism and nutrition disorders
Dehydration
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
1.0%
4/384 • Number of events 4 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Urinary tract infection
|
4.2%
16/385 • Number of events 19 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
2.9%
11/384 • Number of events 15 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Uterine infection
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Wound abscess
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
1.0%
4/384 • Number of events 4 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.52%
2/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.78%
3/385 • Number of events 3 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Injury, poisoning and procedural complications
Radiation proctitis
|
1.6%
6/385 • Number of events 6 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.52%
2/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Injury, poisoning and procedural complications
Uterine perforation
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.52%
2/384 • Number of events 2 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Retroperitoneal abscess
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Salpingitis
|
0.26%
1/385 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.00%
0/384 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Sepsis
|
0.78%
3/385 • Number of events 3 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Ureteritis
|
0.00%
0/385 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
0.26%
1/384 • Number of events 1 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
Other adverse events
| Measure |
Durva + SoC CCRT
n=385 participants at risk
Description (Arm-group)
|
Placebo + SoC CCRT
n=384 participants at risk
Description (Arm-group)
|
|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
8.8%
34/385 • Number of events 56 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
7.8%
30/384 • Number of events 38 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
Blood alkaline phosphatase increased
|
5.5%
21/385 • Number of events 30 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
3.4%
13/384 • Number of events 17 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
Blood creatinine increased
|
8.1%
31/385 • Number of events 48 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
6.0%
23/384 • Number of events 30 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.8%
30/385 • Number of events 41 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
7.3%
28/384 • Number of events 37 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
Lymphocyte count decreased
|
4.7%
18/385 • Number of events 29 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
8.9%
34/384 • Number of events 47 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
Neutrophil count decreased
|
19.2%
74/385 • Number of events 216 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
22.1%
85/384 • Number of events 221 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
Platelet count decreased
|
12.5%
48/385 • Number of events 81 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
16.1%
62/384 • Number of events 107 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.9%
38/385 • Number of events 46 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
7.3%
28/384 • Number of events 38 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
Weight decreased
|
11.2%
43/385 • Number of events 46 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
10.9%
42/384 • Number of events 53 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
White blood cell count decreased
|
18.4%
71/385 • Number of events 296 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
22.1%
85/384 • Number of events 340 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.1%
89/385 • Number of events 103 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
16.7%
64/384 • Number of events 74 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.8%
26/385 • Number of events 28 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
4.9%
19/384 • Number of events 23 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.2%
24/385 • Number of events 32 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
6.5%
25/384 • Number of events 34 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.4%
44/385 • Number of events 63 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
12.0%
46/384 • Number of events 74 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.4%
40/385 • Number of events 52 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
9.9%
38/384 • Number of events 61 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.5%
29/385 • Number of events 40 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
6.0%
23/384 • Number of events 29 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.4%
44/385 • Number of events 51 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
10.9%
42/384 • Number of events 49 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.4%
40/385 • Number of events 47 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
11.2%
43/384 • Number of events 45 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.8%
26/385 • Number of events 29 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
3.6%
14/384 • Number of events 18 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Nervous system disorders
Dizziness
|
4.9%
19/385 • Number of events 24 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
5.2%
20/384 • Number of events 25 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Nervous system disorders
Headache
|
10.9%
42/385 • Number of events 55 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
11.2%
43/384 • Number of events 51 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Psychiatric disorders
Insomnia
|
10.6%
41/385 • Number of events 47 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
8.6%
33/384 • Number of events 34 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Renal and urinary disorders
Dysuria
|
15.8%
61/385 • Number of events 74 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
18.2%
70/384 • Number of events 80 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Endocrine disorders
Hyperthyroidism
|
6.8%
26/385 • Number of events 27 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
3.1%
12/384 • Number of events 13 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Reproductive system and breast disorders
Pelvic pain
|
10.4%
40/385 • Number of events 48 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
9.6%
37/384 • Number of events 41 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Reproductive system and breast disorders
Vaginal discharge
|
7.8%
30/385 • Number of events 37 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
7.3%
28/384 • Number of events 31 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
6.2%
24/385 • Number of events 28 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
7.6%
29/384 • Number of events 33 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Endocrine disorders
Hypothyroidism
|
15.6%
60/385 • Number of events 68 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
5.5%
21/384 • Number of events 21 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Vascular disorders
Hot flush
|
7.3%
28/385 • Number of events 31 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
5.5%
21/384 • Number of events 24 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Vascular disorders
Hypertension
|
4.2%
16/385 • Number of events 25 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
6.2%
24/384 • Number of events 31 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Abdominal distension
|
5.2%
20/385 • Number of events 21 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
2.9%
11/384 • Number of events 13 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Blood and lymphatic system disorders
Anaemia
|
54.3%
209/385 • Number of events 315 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
52.1%
200/384 • Number of events 322 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Abdominal pain
|
13.0%
50/385 • Number of events 71 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
14.1%
54/384 • Number of events 68 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.8%
30/385 • Number of events 31 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
5.2%
20/384 • Number of events 23 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Constipation
|
25.2%
97/385 • Number of events 119 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
22.7%
87/384 • Number of events 106 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Diarrhoea
|
46.0%
177/385 • Number of events 257 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
49.5%
190/384 • Number of events 289 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.6%
14/385 • Number of events 14 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
6.0%
23/384 • Number of events 24 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Nausea
|
55.3%
213/385 • Number of events 289 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
52.6%
202/384 • Number of events 293 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
105/385 • Number of events 194 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
27.9%
107/384 • Number of events 202 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
General disorders
Asthenia
|
8.8%
34/385 • Number of events 45 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
9.1%
35/384 • Number of events 43 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
General disorders
Fatigue
|
13.5%
52/385 • Number of events 55 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
18.2%
70/384 • Number of events 79 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
General disorders
Pyrexia
|
9.1%
35/385 • Number of events 51 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
8.3%
32/384 • Number of events 37 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.3%
59/385 • Number of events 100 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
15.1%
58/384 • Number of events 120 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Covid-19
|
7.5%
29/385 • Number of events 29 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
10.4%
40/384 • Number of events 46 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Cystitis
|
6.5%
25/385 • Number of events 28 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
4.9%
19/384 • Number of events 21 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.1%
39/385 • Number of events 59 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
7.6%
29/384 • Number of events 51 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Herpes zoster
|
5.7%
22/385 • Number of events 24 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
1.0%
4/384 • Number of events 5 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
26/385 • Number of events 27 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
3.6%
14/384 • Number of events 19 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Infections and infestations
Urinary tract infection
|
23.4%
90/385 • Number of events 123 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
24.0%
92/384 • Number of events 124 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Blood and lymphatic system disorders
Neutropenia
|
19.2%
74/385 • Number of events 120 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
14.3%
55/384 • Number of events 100 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
5.2%
20/385 • Number of events 21 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
2.6%
10/384 • Number of events 10 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Injury, poisoning and procedural complications
Radiation proctitis
|
6.5%
25/385 • Number of events 27 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
6.8%
26/384 • Number of events 26 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
4.4%
17/385 • Number of events 18 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
7.0%
27/384 • Number of events 27 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
|
Investigations
Alanine aminotransferase increased
|
11.2%
43/385 • Number of events 64 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
9.6%
37/384 • Number of events 48 • From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
There were 385 subjects randomised to each of Durva + SoC CCRT and Placebo + SoC CCRT respectively (Full Analysis Set), however 1 of the subjects allocated to Placebo + SoC CCRT did not receive treatment (resulting in 384 in the Safety Analysis Set). Hence, for Placebo + SoC CCRT, the Total number at risk for all-cause mortality = 385 while the Total # at Risk by any Serious Adverse Event = 384 and the Total # at Risk by any Other Adverse Event = 384
|
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