Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study is active, not recruiting and conducted in 17 countries with 685 patients who were randomized prior to or on 18 December 2020. Results are reported for the study at data cut-off (DCO) 28 February 2025.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible patients previously untreated for unresectable locally advanced or metastatic Biliary Tract Cancer (BTC) were randomized in a 1:1 ratio with either Durvalumab in combination with Gemcitabine/Cisplatin or Placebo in combination with Gemcitabine/Cisplatin. Randomization was stratified by disease status (initially unresectable versus recurrent) and primary tumor site (IHCC versus EHCC versus GBC).

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Participant Flow:   Overall Study

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
 STARTED  341 344
 Treated  338 342
 COMPLETED  0 0
 NOT COMPLETED  341 344
  Ongoing study treatment   7 0
  Off treatment   17 8
  Withdrawal by Subject   6 8
  Death   308 326
  Lost to Follow-up   3 1
  Re-consent refusal   0 1

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.
Baseline analysis was based on all patients in the full analysis set (FAS), which comprised all patients randomized prior to or on 18 December 2020. Patients were included in the analysis in the treatment arm to which they were randomized, regardless of the treatment they received.

Reporting Groups

Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Baseline Measures

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin Total
Number of Participants
[units: Participants] 		341 344 685
Age Continuous
[units: Years]
Mean ± Standard Deviation		 62.2 ± 10.49 62.6 ± 10.66 62.4 ± 10.57
Age, Customized
[units: ]

Age group (years)
      
< 65 years 181 184 365
>=65 - < 75 years 122 114 236
>= 75 years 38 46 84
Sex: Female, Male
[units: ]
     
Female 172 168 340
Male 169 176 345
Race/Ethnicity, Customized
[units: ]

Race
      
American Indian of Alaska Native 0 1 1
Asian 185 201 386
Black or African American 8 6 14
White 131 124 255
Other 17 12 29

Outcome Measures

1. Primary Outcome Measure: Overall Survival (OS)   [ Time Frame: From date of randomization until death due to any cause. Assessed up to maximum of approximately 27 months (from date of randomization to primary analysis data cut-off) ]

Measure Type Primary
Measure Name Overall Survival (OS)
Measure Description Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).
Time Frame From date of randomization until death due to any cause. Assessed up to maximum of approximately 27 months (from date of randomization to primary analysis data cut-off)
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Measured Values

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Number of Participants Analyzed
[units:participants]
 341 344
Overall Survival (OS)
[units: Months]
Median (95% Confidence Interval) 		12.8 (11.1 to 14.0) 11.5 (10.1 to 12.5)

Statistical Analysis 1 for Overall Survival (OS)

Groups  [1] All groups
Method  [3] Log Rank
P-Value  [4] 0.021
Hazard Ratio (HR)  [5] 0.80
97% Confidence Interval ( 0.64 to 0.99 )
[1]  Additional details about the analysis, such as null hypothesis and power calculation:
  The 2-sided significance level for OS at the second interim analysis was 3%.
[3]  Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[4]  Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The analysis was performed using a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.03 significance level.
[5]  Other relevant estimation information:
  The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.

2. Primary Outcome Measure: Overall Survival (OS) rate at 18 months   [ Time Frame: From date of randomization until death due to any cause. Calculated at 18 months using the Kaplan-Meier technique. ]

Measure Type Primary
Measure Name Overall Survival (OS) rate at 18 months
Measure Description Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).
Time Frame From date of randomization until death due to any cause. Calculated at 18 months using the Kaplan-Meier technique.
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Measured Values

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Number of Participants Analyzed
[units:participants]
 341 344
Overall Survival (OS) rate at 18 months
[units: Percentage of Participants]
Number (95% Confidence Interval) 		35.1 (29.1 to 41.2) 25.6 (19.9 to 31.7)

No statistical analysis provided for Overall Survival (OS) rate at 18 months

3. Primary Outcome Measure: Overall Survival (OS) rate at 24 months   [ Time Frame: From date of randomization until death due to any cause. Calculated at 24 months using the Kaplan-Meier technique. ]

Measure Type Primary
Measure Name Overall Survival (OS) rate at 24 months
Measure Description Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).
Time Frame From date of randomization until death due to any cause. Calculated at 24 months using the Kaplan-Meier technique.
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Measured Values

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Number of Participants Analyzed
[units:participants]
 341 344
Overall Survival (OS) rate at 24 months
[units: Percentage of Participants]
Number (95% Confidence Interval) 		24.9 (17.9 to 32.5) 10.4 (4.7 to 18.8)

No statistical analysis provided for Overall Survival (OS) rate at 24 months

4. Secondary Outcome Measure: Progression-free survival (PFS)   [ Time Frame: Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Assessed up to maximum of approximately 27 months. ]

Measure Type Secondary
Measure Name Progression-free survival (PFS)
Measure Description PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
Time Frame Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Assessed up to maximum of approximately 27 months.
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Measured Values

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Number of Participants Analyzed
[units:participants]
 341 344
Progression-free survival (PFS)
[units: Months]
Median (95% Confidence Interval) 		7.2 (6.7 to 7.4) 5.7 (5.6 to 6.7)

Statistical Analysis 1 for Progression-free survival (PFS)

Groups  [1] All groups
Method  [3] Log Rank
P-Value  [4] 0.001
Hazard Ratio (HR)  [5] 0.75
95.19% Confidence Interval ( 0.63 to 0.89 )
[1]  Additional details about the analysis, such as null hypothesis and power calculation:
  The 2-sided significance level for PFS at the second interim analysis was 4.81%.
[3]  Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[4]  Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The p-value is based on a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.0481 significance level.
[5]  Other relevant estimation information:
  The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.

5. Secondary Outcome Measure: Progression-free survival (PFS) rate at 9 months   [ Time Frame: Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Calculated at 9 months using the Kaplan-Meier technique. ]

Measure Type Secondary
Measure Name Progression-free survival (PFS) rate at 9 months
Measure Description PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
Time Frame Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Calculated at 9 months using the Kaplan-Meier technique.
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Measured Values

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Number of Participants Analyzed
[units:participants]
 341 344
Progression-free survival (PFS) rate at 9 months
[units: Percentage of Participants]
Number (95% Confidence Interval) 		34.8 (29.6 to 40.0) 24.6 (20.0 to 29.5)

No statistical analysis provided for Progression-free survival (PFS) rate at 9 months

6. Secondary Outcome Measure: Progression-free survival (PFS) rate at 12 months   [ Time Frame: Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Calculated at 12 months using the Kaplan-Meier technique ]

Measure Type Secondary
Measure Name Progression-free survival (PFS) rate at 12 months
Measure Description PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
Time Frame Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Calculated at 12 months using the Kaplan-Meier technique
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Measured Values

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Number of Participants Analyzed
[units:participants]
 341 344
Progression-free survival (PFS) rate at 12 months
[units: Percentage of Participants]
Number (95% Confidence Interval) 		16.0 (12.0 to 20.6) 6.6 (4.1 to 9.9)

No statistical analysis provided for Progression-free survival (PFS) rate at 12 months

7. Secondary Outcome Measure: Objective Response Rate (ORR)   [ Time Frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months. ]

Measure Type Secondary
Measure Name Objective Response Rate (ORR)
Measure Description Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR was defined as 2 CRs or 2 PRs with no evidence of progression in-between. Patients who discontinued randomized treatment without progression, received a subsequent anti-cancer therapy and then responded were not included as responders for ORR.
Time Frame Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months.
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set - subjects with measurable disease at baseline

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Measured Values

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Number of Participants Analyzed
[units:participants]
 341 343
Objective Response Rate (ORR)
[units: Percentage of Participants]
 26.7 18.7

Statistical Analysis 1 for Objective Response Rate (ORR)

Groups  [1] All groups
Method  [3] Cochran-Mantel-Haenszel
P-Value  [4] 0.011
Odds Ratio (OR)  [5] 1.60
95% Confidence Interval ( 1.11 to 2.31 )
[1]  Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[3]  Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[4]  Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5]  Other relevant estimation information:
  OR and CI were estimated from a stratified CMH test adjusting for disease status and primary tumor location.

8. Secondary Outcome Measure: Duration of Response (DoR)   [ Time Frame: Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months. ]

Measure Type Secondary
Measure Name Duration of Response (DoR)
Measure Description The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression (i.e. date of PFS event or censoring – date of first response + 1) . A confirmed CR was defined in above outcome measures. The PD was defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. Median DoR was calculated using Kaplan-Meier method.
Time Frame Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months.
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set - subjects with objective response and measurable disease at baseline

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Measured Values

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Number of Participants Analyzed
[units:participants]
 91 64
Duration of Response (DoR)
[units: Months]
Median (95% Confidence Interval) 		6.4 (5.9 to 8.1) 6.2 (4.4 to 7.3)

No statistical analysis provided for Duration of Response (DoR)

9. Secondary Outcome Measure: Duration of Response (DoR): percentage remaining in response at 9 months   [ Time Frame: Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Calculated at 9 months using the Kaplan-Meier technique ]

Measure Type Secondary
Measure Name Duration of Response (DoR): percentage remaining in response at 9 months
Measure Description The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression (i.e. date of PFS event or censoring – date of first response + 1) . A confirmed CR was defined in above outcome measures. The PD was defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. Median DoR was calculated using Kaplan-Meier method.
Time Frame Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Calculated at 9 months using the Kaplan-Meier technique
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set - subjects with objective response and measurable disease at baseline

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Measured Values

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Number of Participants Analyzed
[units:participants]
 91 64
Duration of Response (DoR): percentage remaining in response at 9 months
[units: Percentage of Participants]
 32.6 25.3

No statistical analysis provided for Duration of Response (DoR): percentage remaining in response at 9 months

10. Secondary Outcome Measure: Duration of Response (DoR): percentage remaining in response at 12 months   [ Time Frame: Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Calculated at 12 months using the Kaplan-Meier technique ]

Measure Type Secondary
Measure Name Duration of Response (DoR): percentage remaining in response at 12 months
Measure Description The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression (i.e. date of PFS event or censoring – date of first response + 1) . A confirmed CR was defined in above outcome measures. The PD was defined at least 20% increase in sum of diameters of target lesions (compared with nadir at 2 consecutive visits with an absolute increase of 5 mm), unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. Median DoR was calculated using Kaplan-Meier method.
Time Frame Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Calculated at 12 months using the Kaplan-Meier technique
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set - subjects with objective response and measurable disease at baseline

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Measured Values

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Number of Participants Analyzed
[units:participants]
 91 64
Duration of Response (DoR): percentage remaining in response at 12 months
[units: Percentage of Participants]
 26.1 15.0

No statistical analysis provided for Duration of Response (DoR): percentage remaining in response at 12 months

11. Secondary Outcome Measure: Disease Control Rate (DCR) - Overall   [ Time Frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months. ]

Measure Type Secondary
Measure Name Disease Control Rate (DCR) - Overall
Measure Description Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD).
Time Frame Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months.
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Measured Values

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Number of Participants Analyzed
[units:participants]
 341 344
Disease Control Rate (DCR) - Overall
[units: Percentage of Participants]
 85.3 82.6

No statistical analysis provided for Disease Control Rate (DCR) - Overall

12. Secondary Outcome Measure: Disease Control Rate (DCR) - 24 weeks   [ Time Frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization. ]

Measure Type Secondary
Measure Name Disease Control Rate (DCR) - 24 weeks
Measure Description Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR) or partial response (PR) by week 24 or who have stable disease (SD) at least 24 weeks following start of treatment.
Time Frame Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization.
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Measured Values

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Number of Participants Analyzed
[units:participants]
 341 344
Disease Control Rate (DCR) - 24 weeks
[units: Percentage of Participants]
 57.5 48.3

No statistical analysis provided for Disease Control Rate (DCR) - 24 weeks

13. Secondary Outcome Measure: Disease Control Rate (DCR) - 32 weeks   [ Time Frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. ]

Measure Type Secondary
Measure Name Disease Control Rate (DCR) - 32 weeks
Measure Description Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR) or partial response (PR) by week 32 or who have stable disease (SD) at least 32 weeks following start of treatment.
Time Frame Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter.
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Measured Values

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Number of Participants Analyzed
[units:participants]
 341 344
Disease Control Rate (DCR) - 32 weeks
[units: Percentage of Participants]
 41.9 36.3

No statistical analysis provided for Disease Control Rate (DCR) - 32 weeks

14. Secondary Outcome Measure: Disease Control Rate (DCR) - 48 weeks   [ Time Frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. ]

Measure Type Secondary
Measure Name Disease Control Rate (DCR) - 48 weeks
Measure Description Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR) or partial response (PR) by week 48 or who have stable disease (SD) at least 48 weeks following start of treatment.
Time Frame Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter.
Safety Issue? No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo
IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Measured Values

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Number of Participants Analyzed
[units:participants]
 341 344
Disease Control Rate (DCR) - 48 weeks
[units: Percentage of Participants]
 35.2 27.0

No statistical analysis provided for Disease Control Rate (DCR) - 48 weeks

Serious Adverse Events

Time Frame Adverse events: from first dose of study medication up to 90 days after the last dose of study medication or until the initiation of the first subsequent therapy (whichever comes first), up to maximum of approximately 67 months. All-cause mortality (death due to any cause): from randomization up to analysis DCO (28 February 2025). Maximum timeframe of approximately 67 months.
Additional Description There were 341 patients randomized to Durvalumab + Gemcitabine + Cisplatin and 344 patients randomized to Placebo + Gemcitabine + Cisplatin (Full Analysis Set). Five of these patients did not receive treatment (resulting in 338 in Durvalumab arm and 342 in Placebo arm for Safety Analysis Set). Hence, the Total numbers at risk for all-cause mortality is 341 (Durvalumab) and 344 (Placebo), while the Total number at Risk by any Serious/Other Adverse Event is 338 (Durvalumab) and 342 (Placebo).

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Serious Adverse Events

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Total, serious adverse events    
# participants affected / at risk 168/338 (49.70%) 152/342 (44.44%)
Cardiac disorders    
Acute coronary syndrome1, †    
# participants affected / at risk 2/338 (0.59%) 0/342 (0.00%)
# events 2 0
Infections and infestations    
Device related sepsis1, †    
# participants affected / at risk 1/338 (0.30%) 1/342 (0.29%)
# events 1 1
Infections and infestations    
Escherichia sepsis1, †    
# participants affected / at risk 1/338 (0.30%) 1/342 (0.29%)
# events 1 1
Infections and infestations    
Gallbladder empyema1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Infections and infestations    
Gastroenteritis escherichia coli1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Infections and infestations    
Hepatic infection1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Infections and infestations    
Infection1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Infections and infestations    
Infectious pleural effusion1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Infections and infestations    
Klebsiella infection1, †    
# participants affected / at risk 0/338 (0.00%) 2/342 (0.58%)
# events 0 2
Infections and infestations    
Liver abscess1, †    
# participants affected / at risk 1/338 (0.30%) 2/342 (0.58%)
# events 1 2
Infections and infestations    
Lower respiratory tract infection1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Cardiac disorders    
Angina pectoris1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Infections and infestations    
Nasopharyngitis1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Infections and infestations    
Neutropenic sepsis1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Infections and infestations    
Peritonitis1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Infections and infestations    
Pneumocystis jirovecii pneumonia1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Infections and infestations    
Pneumonia1, †    
# participants affected / at risk 7/338 (2.07%) 8/342 (2.34%)
# events 8 9
Infections and infestations    
Pyelonephritis1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Infections and infestations    
Sepsis1, †    
# participants affected / at risk 12/338 (3.55%) 9/342 (2.63%)
# events 12 12
Infections and infestations    
Septic shock1, †    
# participants affected / at risk 1/338 (0.30%) 4/342 (1.17%)
# events 1 6
Infections and infestations    
Urinary tract infection1, †    
# participants affected / at risk 6/338 (1.78%) 1/342 (0.29%)
# events 6 1
Injury, poisoning and procedural complications    
Ankle fracture1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Cardiac disorders    
Atrial fibrillation1, †    
# participants affected / at risk 2/338 (0.59%) 0/342 (0.00%)
# events 2 0
Injury, poisoning and procedural complications    
Chemical peritonitis1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Injury, poisoning and procedural complications    
Fall1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Injury, poisoning and procedural complications    
Femoral neck fracture1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Injury, poisoning and procedural complications    
Femur fracture1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Injury, poisoning and procedural complications    
Incisional hernia1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Injury, poisoning and procedural complications    
Infusion related reaction1, †    
# participants affected / at risk 1/338 (0.30%) 1/342 (0.29%)
# events 1 1
Injury, poisoning and procedural complications    
Lower limb fracture1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Injury, poisoning and procedural complications    
Overdose1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Injury, poisoning and procedural complications    
Post procedural complication1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Injury, poisoning and procedural complications    
Procedural pain1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Cardiac disorders    
Sinus tachycardia1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Injury, poisoning and procedural complications    
Spinal fracture1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Injury, poisoning and procedural complications    
Transfusion reaction1, †    
# participants affected / at risk 1/338 (0.30%) 1/342 (0.29%)
# events 1 1
Investigations    
Alanine aminotransferase increased1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Investigations    
Blood bilirubin increased1, †    
# participants affected / at risk 1/338 (0.30%) 4/342 (1.17%)
# events 1 4
Investigations    
Blood creatinine increased1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Investigations    
Liver function test increased1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Investigations    
Neutrophil count decreased1, †    
# participants affected / at risk 3/338 (0.89%) 2/342 (0.58%)
# events 4 2
Investigations    
Platelet count decreased1, †    
# participants affected / at risk 4/338 (1.18%) 3/342 (0.88%)
# events 4 3
Ear and labyrinth disorders    
Vertigo1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Metabolism and nutrition disorders    
Decreased appetite1, †    
# participants affected / at risk 4/338 (1.18%) 2/342 (0.58%)
# events 4 2
Metabolism and nutrition disorders    
Diabetes mellitus1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Metabolism and nutrition disorders    
Diabetic ketoacidosis1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Metabolism and nutrition disorders    
Gout1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Metabolism and nutrition disorders    
Hypercalcaemia1, †    
# participants affected / at risk 2/338 (0.59%) 1/342 (0.29%)
# events 3 1
Metabolism and nutrition disorders    
Hyperglycaemia1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Metabolism and nutrition disorders    
Hyperkalaemia1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Metabolism and nutrition disorders    
Hypoglycaemia1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Endocrine disorders    
Adrenal insufficiency1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Metabolism and nutrition disorders    
Hypokalaemia1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Metabolism and nutrition disorders    
Hypomagnesaemia1, †    
# participants affected / at risk 1/338 (0.30%) 1/342 (0.29%)
# events 1 1
Metabolism and nutrition disorders    
Hyponatraemia1, †    
# participants affected / at risk 1/338 (0.30%) 1/342 (0.29%)
# events 1 1
Musculoskeletal and connective tissue disorders    
Arthritis1, †    
# participants affected / at risk 0/338 (0.00%) 2/342 (0.58%)
# events 0 2
Musculoskeletal and connective tissue disorders    
Back pain1, †    
# participants affected / at risk 1/338 (0.30%) 1/342 (0.29%)
# events 1 1
Musculoskeletal and connective tissue disorders    
Immune-mediated arthritis1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Musculoskeletal and connective tissue disorders    
Polymyositis1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Cancer pain1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Colorectal cancer1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Tumour associated fever1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Tumour haemorrhage1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)    
Tumour pain1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Nervous system disorders    
Altered state of consciousness1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Nervous system disorders    
Cerebral haemorrhage1, †    
# participants affected / at risk 2/338 (0.59%) 0/342 (0.00%)
# events 2 0
Nervous system disorders    
Cerebral infarction1, †    
# participants affected / at risk 1/338 (0.30%) 1/342 (0.29%)
# events 1 1
Nervous system disorders    
Cerebrovascular accident1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Nervous system disorders    
Cognitive disorder1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Nervous system disorders    
Dizziness1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Eye disorders    
Cataract1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Nervous system disorders    
Encephalopathy1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Nervous system disorders    
Hepatic encephalopathy1, †    
# participants affected / at risk 1/338 (0.30%) 1/342 (0.29%)
# events 1 1
Nervous system disorders    
Ischaemic stroke1, †    
# participants affected / at risk 4/338 (1.18%) 1/342 (0.29%)
# events 4 1
Nervous system disorders    
Syncope1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Product issues    
Device malfunction1, †    
# participants affected / at risk 2/338 (0.59%) 2/342 (0.58%)
# events 2 3
Product issues    
Device occlusion1, †    
# participants affected / at risk 0/338 (0.00%) 4/342 (1.17%)
# events 0 4
Product issues    
Embedded device1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Product issues    
Stent malfunction1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Eye disorders    
Optic ischaemic neuropathy1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Psychiatric disorders    
Adjustment disorder1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 2
Psychiatric disorders    
Confusional state1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Psychiatric disorders    
Personality change1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Psychiatric disorders    
Suicide attempt1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Renal and urinary disorders    
Acute kidney injury1, †    
# participants affected / at risk 8/338 (2.37%) 5/342 (1.46%)
# events 11 5
Renal and urinary disorders    
Azotaemia1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 2 0
Renal and urinary disorders    
Haematuria1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Renal and urinary disorders    
Nephropathy toxic1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Renal and urinary disorders    
Renal failure1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Gastrointestinal disorders    
Abdominal distension1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Renal and urinary disorders    
Urinary tract obstruction1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Respiratory, thoracic and mediastinal disorders    
Acute respiratory failure1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Respiratory, thoracic and mediastinal disorders    
Asphyxia1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Respiratory, thoracic and mediastinal disorders    
Dyspnoea1, †    
# participants affected / at risk 0/338 (0.00%) 2/342 (0.58%)
# events 0 2
Respiratory, thoracic and mediastinal disorders    
Hiccups1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Respiratory, thoracic and mediastinal disorders    
Interstitial lung disease1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Respiratory, thoracic and mediastinal disorders    
Obstructive airways disorder1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Respiratory, thoracic and mediastinal disorders    
Pleural effusion1, †    
# participants affected / at risk 1/338 (0.30%) 1/342 (0.29%)
# events 1 1
Respiratory, thoracic and mediastinal disorders    
Pneumonia aspiration1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Blood and lymphatic system disorders    
Anaemia1, †    
# participants affected / at risk 12/338 (3.55%) 4/342 (1.17%)
# events 17 4
Gastrointestinal disorders    
Abdominal pain1, †    
# participants affected / at risk 1/338 (0.30%) 8/342 (2.34%)
# events 1 8
Respiratory, thoracic and mediastinal disorders    
Pneumonitis1, †    
# participants affected / at risk 2/338 (0.59%) 2/342 (0.58%)
# events 2 2
Respiratory, thoracic and mediastinal disorders    
Pneumothorax1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 2
Respiratory, thoracic and mediastinal disorders    
Pulmonary embolism1, †    
# participants affected / at risk 6/338 (1.78%) 4/342 (1.17%)
# events 6 4
Respiratory, thoracic and mediastinal disorders    
Pulmonary oedema1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Respiratory, thoracic and mediastinal disorders    
Respiratory failure1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Skin and subcutaneous tissue disorders    
Rash maculo-papular1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Vascular disorders    
Angiopathy1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Gastrointestinal disorders    
Abdominal pain upper1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Vascular disorders    
Arterial thrombosis1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Vascular disorders    
Deep vein thrombosis1, †    
# participants affected / at risk 1/338 (0.30%) 2/342 (0.58%)
# events 1 2
Vascular disorders    
Hypertension1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Vascular disorders    
Hypotension1, †    
# participants affected / at risk 1/338 (0.30%) 2/342 (0.58%)
# events 1 2
Vascular disorders    
Jugular vein thrombosis1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Vascular disorders    
Peripheral artery thrombosis1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Vascular disorders    
Thrombosis1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Vascular disorders    
Venous thrombosis1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Gastrointestinal disorders    
Anal fistula1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Gastrointestinal disorders    
Ascites1, †    
# participants affected / at risk 4/338 (1.18%) 6/342 (1.75%)
# events 5 6
Gastrointestinal disorders    
Diarrhoea1, †    
# participants affected / at risk 4/338 (1.18%) 5/342 (1.46%)
# events 4 6
Gastrointestinal disorders    
Duodenal obstruction1, †    
# participants affected / at risk 0/338 (0.00%) 2/342 (0.58%)
# events 0 3
Gastrointestinal disorders    
Duodenal stenosis1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Gastrointestinal disorders    
Duodenal ulcer1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Blood and lymphatic system disorders    
Bicytopenia1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Gastrointestinal disorders    
Fistula of small intestine1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Gastrointestinal disorders    
Gastric perforation1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Gastrointestinal disorders    
Gastritis1, †    
# participants affected / at risk 0/338 (0.00%) 2/342 (0.58%)
# events 0 2
Gastrointestinal disorders    
Haematochezia1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 2 0
Gastrointestinal disorders    
Ileus1, †    
# participants affected / at risk 3/338 (0.89%) 3/342 (0.88%)
# events 3 3
Gastrointestinal disorders    
Immune-mediated enterocolitis1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Gastrointestinal disorders    
Inguinal hernia1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Gastrointestinal disorders    
Intestinal obstruction1, †    
# participants affected / at risk 2/338 (0.59%) 0/342 (0.00%)
# events 3 0
Gastrointestinal disorders    
Large intestine perforation1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Gastrointestinal disorders    
Lower gastrointestinal haemorrhage1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Blood and lymphatic system disorders    
Febrile neutropenia1, †    
# participants affected / at risk 4/338 (1.18%) 5/342 (1.46%)
# events 4 5
Gastrointestinal disorders    
Melaena1, †    
# participants affected / at risk 1/338 (0.30%) 1/342 (0.29%)
# events 1 1
Gastrointestinal disorders    
Nausea1, †    
# participants affected / at risk 1/338 (0.30%) 3/342 (0.88%)
# events 1 3
Gastrointestinal disorders    
Obstruction gastric1, †    
# participants affected / at risk 2/338 (0.59%) 0/342 (0.00%)
# events 2 0
Gastrointestinal disorders    
Pancreatitis1, †    
# participants affected / at risk 3/338 (0.89%) 0/342 (0.00%)
# events 3 0
Gastrointestinal disorders    
Pancreatitis acute1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Gastrointestinal disorders    
Rectal haemorrhage1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 2 0
Gastrointestinal disorders    
Small intestinal obstruction1, †    
# participants affected / at risk 1/338 (0.30%) 2/342 (0.58%)
# events 1 2
Gastrointestinal disorders    
Upper gastrointestinal haemorrhage1, †    
# participants affected / at risk 5/338 (1.48%) 2/342 (0.58%)
# events 6 2
Gastrointestinal disorders    
Vomiting1, †    
# participants affected / at risk 5/338 (1.48%) 5/342 (1.46%)
# events 6 5
General disorders and administration site conditions    
Asthenia1, †    
# participants affected / at risk 1/338 (0.30%) 2/342 (0.58%)
# events 1 2
General disorders and administration site conditions    
Death1, †    
# participants affected / at risk 0/338 (0.00%) 2/342 (0.58%)
# events 0 2
General disorders and administration site conditions    
Device related thrombosis1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
General disorders and administration site conditions    
Fatigue1, †    
# participants affected / at risk 6/338 (1.78%) 4/342 (1.17%)
# events 6 4
General disorders and administration site conditions    
Malaise1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
General disorders and administration site conditions    
Mucosal inflammation1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
General disorders and administration site conditions    
Pain1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
General disorders and administration site conditions    
Peripheral swelling1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
General disorders and administration site conditions    
Pyrexia1, †    
# participants affected / at risk 15/338 (4.44%) 8/342 (2.34%)
# events 18 8
Blood and lymphatic system disorders    
Myelosuppression1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
General disorders and administration site conditions    
Sudden death1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Hepatobiliary disorders    
Autoimmune hepatitis1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Hepatobiliary disorders    
Biliary obstruction1, †    
# participants affected / at risk 8/338 (2.37%) 7/342 (2.05%)
# events 10 8
Hepatobiliary disorders    
Biloma rupture1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Hepatobiliary disorders    
Cholangitis1, †    
# participants affected / at risk 25/338 (7.40%) 17/342 (4.97%)
# events 42 22
Hepatobiliary disorders    
Cholangitis acute1, †    
# participants affected / at risk 6/338 (1.78%) 4/342 (1.17%)
# events 7 7
Hepatobiliary disorders    
Cholecystitis1, †    
# participants affected / at risk 1/338 (0.30%) 4/342 (1.17%)
# events 3 4
Hepatobiliary disorders    
Cholecystitis acute1, †    
# participants affected / at risk 1/338 (0.30%) 1/342 (0.29%)
# events 1 1
Hepatobiliary disorders    
Cholestasis1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Hepatobiliary disorders    
Gallbladder obstruction1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Blood and lymphatic system disorders    
Neutropenia1, †    
# participants affected / at risk 2/338 (0.59%) 3/342 (0.88%)
# events 3 3
Hepatobiliary disorders    
Gallbladder rupture1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Hepatobiliary disorders    
Hepatic cytolysis1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Hepatobiliary disorders    
Hepatic failure1, †    
# participants affected / at risk 1/338 (0.30%) 1/342 (0.29%)
# events 1 1
Hepatobiliary disorders    
Hepatic function abnormal1, †    
# participants affected / at risk 1/338 (0.30%) 1/342 (0.29%)
# events 1 1
Hepatobiliary disorders    
Hepatic haemorrhage1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 2 0
Hepatobiliary disorders    
Hepatitis1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Hepatobiliary disorders    
Hyperbilirubinaemia1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Hepatobiliary disorders    
Jaundice1, †    
# participants affected / at risk 0/338 (0.00%) 2/342 (0.58%)
# events 0 2
Hepatobiliary disorders    
Jaundice cholestatic1, †    
# participants affected / at risk 4/338 (1.18%) 6/342 (1.75%)
# events 4 6
Hepatobiliary disorders    
Portal vein thrombosis1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Blood and lymphatic system disorders    
Pancytopenia1, †    
# participants affected / at risk 2/338 (0.59%) 1/342 (0.29%)
# events 2 1
Hepatobiliary disorders    
Portosplenomesenteric venous thrombosis1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Immune system disorders    
Anaphylactic shock1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Infections and infestations    
Abdominal infection1, †    
# participants affected / at risk 1/338 (0.30%) 2/342 (0.58%)
# events 1 2
Infections and infestations    
Abdominal wall abscess1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Infections and infestations    
Abscess intestinal1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Infections and infestations    
Acinetobacter sepsis1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Infections and infestations    
Appendicitis1, †    
# participants affected / at risk 0/338 (0.00%) 2/342 (0.58%)
# events 0 2
Infections and infestations    
Arthritis bacterial1, †    
# participants affected / at risk 1/338 (0.30%) 0/342 (0.00%)
# events 1 0
Infections and infestations    
Bacteraemia1, †    
# participants affected / at risk 1/338 (0.30%) 5/342 (1.46%)
# events 1 5
Infections and infestations    
Biliary abscess1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Blood and lymphatic system disorders    
Thrombocytopenia1, †    
# participants affected / at risk 3/338 (0.89%) 4/342 (1.17%)
# events 3 4
Infections and infestations    
Biliary sepsis1, †    
# participants affected / at risk 5/338 (1.48%) 3/342 (0.88%)
# events 5 3
Infections and infestations    
Biliary tract infection1, †    
# participants affected / at risk 6/338 (1.78%) 7/342 (2.05%)
# events 8 8
Infections and infestations    
Bronchitis1, †    
# participants affected / at risk 2/338 (0.59%) 0/342 (0.00%)
# events 2 0
Infections and infestations    
Covid-191, †    
# participants affected / at risk 4/338 (1.18%) 2/342 (0.58%)
# events 4 2
Infections and infestations    
Covid-19 pneumonia1, †    
# participants affected / at risk 1/338 (0.30%) 1/342 (0.29%)
# events 1 1
Infections and infestations    
Catheter site infection1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Infections and infestations    
Cellulitis1, †    
# participants affected / at risk 2/338 (0.59%) 0/342 (0.00%)
# events 2 0
Infections and infestations    
Cholangitis infective1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Infections and infestations    
Clostridium difficile infection1, †    
# participants affected / at risk 0/338 (0.00%) 1/342 (0.29%)
# events 0 1
Infections and infestations    
Device related infection1, †    
# participants affected / at risk 2/338 (0.59%) 3/342 (0.88%)
# events 3 3
† Events were collected by systematic assessment
1 Term from vocabulary,  MedDRA 24.0

Other Adverse Events

Time Frame Adverse events: from first dose of study medication up to 90 days after the last dose of study medication or until the initiation of the first subsequent therapy (whichever comes first), up to maximum of approximately 67 months. All-cause mortality (death due to any cause): from randomization up to analysis DCO (28 February 2025). Maximum timeframe of approximately 67 months.
Additional Description There were 341 patients randomized to Durvalumab + Gemcitabine + Cisplatin and 344 patients randomized to Placebo + Gemcitabine + Cisplatin (Full Analysis Set). Five of these patients did not receive treatment (resulting in 338 in Durvalumab arm and 342 in Placebo arm for Safety Analysis Set). Hence, the Total numbers at risk for all-cause mortality is 341 (Durvalumab) and 344 (Placebo), while the Total number at Risk by any Serious/Other Adverse Event is 338 (Durvalumab) and 342 (Placebo).

Frequency Threshold

Threshold above which other adverse events are reported 5%

Reporting Groups

  Description
Durvalumab + Gemcitabine + Cisplatin Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.

Other Adverse Events

  Durvalumab + Gemcitabine + Cisplatin Placebo + Gemcitabine + Cisplatin
Total, other (not including serious) adverse events    
# participants affected / at risk 326/338 (96.45%) 330/342 (96.49%)
Infections and infestations    
Urinary tract infection1, †    
# participants affected / at risk 21/338 (6.21%) 20/342 (5.85%)
# events 29 22
Investigations    
Alanine aminotransferase increased1, †    
# participants affected / at risk 31/338 (9.17%) 34/342 (9.94%)
# events 41 44
Investigations    
Aspartate aminotransferase increased1, †    
# participants affected / at risk 25/338 (7.40%) 31/342 (9.06%)
# events 35 39
Investigations    
Blood bilirubin increased1, †    
# participants affected / at risk 11/338 (3.25%) 20/342 (5.85%)
# events 12 22
Investigations    
Blood creatinine increased1, †    
# participants affected / at risk 10/338 (2.96%) 33/342 (9.65%)
# events 12 43
Investigations    
Gamma-glutamyltransferase increased1, †    
# participants affected / at risk 14/338 (4.14%) 18/342 (5.26%)
# events 17 27
Investigations    
Neutrophil count decreased1, †    
# participants affected / at risk 89/338 (26.33%) 105/342 (30.70%)
# events 225 263
Investigations    
Platelet count decreased1, †    
# participants affected / at risk 68/338 (20.12%) 78/342 (22.81%)
# events 127 176
Investigations    
Weight decreased1, †    
# participants affected / at risk 21/338 (6.21%) 21/342 (6.14%)
# events 21 25
Investigations    
White blood cell count decreased1, †    
# participants affected / at risk 37/338 (10.95%) 46/342 (13.45%)
# events 78 106
Metabolism and nutrition disorders    
Decreased appetite1, †    
# participants affected / at risk 86/338 (25.44%) 81/342 (23.68%)
# events 105 94
Metabolism and nutrition disorders    
Hypokalaemia1, †    
# participants affected / at risk 30/338 (8.88%) 17/342 (4.97%)
# events 41 29
Metabolism and nutrition disorders    
Hypomagnesaemia1, †    
# participants affected / at risk 34/338 (10.06%) 29/342 (8.48%)
# events 50 35
Metabolism and nutrition disorders    
Hyponatraemia1, †    
# participants affected / at risk 23/338 (6.80%) 22/342 (6.43%)
# events 26 26
Musculoskeletal and connective tissue disorders    
Arthralgia1, †    
# participants affected / at risk 21/338 (6.21%) 14/342 (4.09%)
# events 23 15
Musculoskeletal and connective tissue disorders    
Back pain1, †    
# participants affected / at risk 29/338 (8.58%) 23/342 (6.73%)
# events 36 25
Musculoskeletal and connective tissue disorders    
Myalgia1, †    
# participants affected / at risk 16/338 (4.73%) 21/342 (6.14%)
# events 21 23
Endocrine disorders    
Hypothyroidism1, †    
# participants affected / at risk 24/338 (7.10%) 11/342 (3.22%)
# events 24 11
Nervous system disorders    
Dizziness1, †    
# participants affected / at risk 21/338 (6.21%) 16/342 (4.68%)
# events 24 20
Nervous system disorders    
Dysgeusia1, †    
# participants affected / at risk 20/338 (5.92%) 16/342 (4.68%)
# events 24 22
Nervous system disorders    
Headache1, †    
# participants affected / at risk 25/338 (7.40%) 15/342 (4.39%)
# events 28 20
Psychiatric disorders    
Insomnia1, †    
# participants affected / at risk 32/338 (9.47%) 36/342 (10.53%)
# events 35 36
Respiratory, thoracic and mediastinal disorders    
Cough1, †    
# participants affected / at risk 22/338 (6.51%) 19/342 (5.56%)
# events 25 20
Respiratory, thoracic and mediastinal disorders    
Dyspnoea1, †    
# participants affected / at risk 22/338 (6.51%) 17/342 (4.97%)
# events 27 20
Blood and lymphatic system disorders    
Anaemia1, †    
# participants affected / at risk 159/338 (47.04%) 150/342 (43.86%)
# events 248 250
Gastrointestinal disorders    
Abdominal pain1, †    
# participants affected / at risk 50/338 (14.79%) 55/342 (16.08%)
# events 64 63
Skin and subcutaneous tissue disorders    
Alopecia1, †    
# participants affected / at risk 28/338 (8.28%) 15/342 (4.39%)
# events 30 15
Skin and subcutaneous tissue disorders    
Pruritus1, †    
# participants affected / at risk 43/338 (12.72%) 29/342 (8.48%)
# events 51 31
Skin and subcutaneous tissue disorders    
Rash1, †    
# participants affected / at risk 40/338 (11.83%) 28/342 (8.19%)
# events 62 35
Skin and subcutaneous tissue disorders    
Rash maculo-papular1, †    
# participants affected / at risk 18/338 (5.33%) 8/342 (2.34%)
# events 22 9
Gastrointestinal disorders    
Abdominal pain upper1, †    
# participants affected / at risk 38/338 (11.24%) 31/342 (9.06%)
# events 46 38
Vascular disorders    
Hypertension1, †    
# participants affected / at risk 19/338 (5.62%) 20/342 (5.85%)
# events 31 23
Gastrointestinal disorders    
Constipation1, †    
# participants affected / at risk 110/338 (32.54%) 101/342 (29.53%)
# events 136 120
Gastrointestinal disorders    
Diarrhoea1, †    
# participants affected / at risk 54/338 (15.98%) 49/342 (14.33%)
# events 70 77
Gastrointestinal disorders    
Dyspepsia1, †    
# participants affected / at risk 23/338 (6.80%) 25/342 (7.31%)
# events 26 27
Gastrointestinal disorders    
Nausea1, †    
# participants affected / at risk 139/338 (41.12%) 124/342 (36.26%)
# events 213 212
Gastrointestinal disorders    
Stomatitis1, †    
# participants affected / at risk 23/338 (6.80%) 22/342 (6.43%)
# events 30 25
Gastrointestinal disorders    
Vomiting1, †    
# participants affected / at risk 61/338 (18.05%) 59/342 (17.25%)
# events 83 88
Blood and lymphatic system disorders    
Leukopenia1, †    
# participants affected / at risk 20/338 (5.92%) 17/342 (4.97%)
# events 43 36
General disorders and administration site conditions    
Asthenia1, †    
# participants affected / at risk 48/338 (14.20%) 50/342 (14.62%)
# events 79 72
General disorders and administration site conditions    
Fatigue1, †    
# participants affected / at risk 90/338 (26.63%) 86/342 (25.15%)
# events 159 124
General disorders and administration site conditions    
Oedema peripheral1, †    
# participants affected / at risk 28/338 (8.28%) 17/342 (4.97%)
# events 34 23
General disorders and administration site conditions    
Pyrexia1, †    
# participants affected / at risk 62/338 (18.34%) 52/342 (15.20%)
# events 101 88
Blood and lymphatic system disorders    
Neutropenia1, †    
# participants affected / at risk 106/338 (31.36%) 101/342 (29.53%)
# events 214 209
Blood and lymphatic system disorders    
Thrombocytopenia1, †    
# participants affected / at risk 42/338 (12.43%) 42/342 (12.28%)
# events 66 76
† Events were collected by systematic assessment
1 Term from vocabulary,  MedDRA 24.0

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title: Global Clinical Lead
Organization: AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479 
E-mail: [email protected]
.