Trial Outcomes & Findings for Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma (NCT NCT02558894)

NCT ID: NCT02558894

Last Updated: 2018-08-02

Results Overview

ORR was defined as the percentage of patients with at least one visit response of confirmed complete response (CR) or partial response (PR). CR was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have had reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of TLs, taking as reference the baseline sum of diameters. A confirmed response meant that a response of CR/PR was recorded at 1 visit and confirmed by repeat imaging, preferably at the next regularly scheduled imaging visit and not less than 4 weeks after the visit when response was first observed with no evidence of progression between the initial and CR/PR confirmation visits. Results are reported as percentage of patients with a confirmed response and percentage of patients with confirmed or unconfirmed responses (i.e., including single visit responses).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 65 participants
• Primary outcome timeframe: From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)
• Results posted on: 2018-08-02

Participant Flow

First patient enrolled: 16 Nov 2015; Part A data cut-off: 26 May 2017. The study contained a Part B which was not opened; only Part A was conducted. Study assessed efficacy of durvalumab (MEDI4736) + tremelimumab combination therapy compared to durvalumab (MEDI4736) monotherapy. Study performed at 21 sites in 6 countries.

65 patients were randomised to receive investigational product (IP) and 64 received treatment. One randomised patient in the durvalumab monotherapy arm was withdrawn prior to receiving any IP but was still included in the full analysis set (FAS) which was used for participant flow and baseline analysis.

Participant milestones

Measure	Durvalumab (MEDI4736) Plus Tremelimumab Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 grams (g) durvalumab and 75 milligrams (mg) tremelimumab via intravenous (IV) infusion every 4 weeks (q4w) over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
Overall Study STARTED	32	33
Overall Study Patients Who Received IP	32	32
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	32	33

Reasons for withdrawal

Measure	Durvalumab (MEDI4736) Plus Tremelimumab Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 grams (g) durvalumab and 75 milligrams (mg) tremelimumab via intravenous (IV) infusion every 4 weeks (q4w) over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
Overall Study Death; any cause, entire study duration	28	31
Overall Study Withdrawal by Subject	2	1
Overall Study Closure of Part A	2	1

Baseline Characteristics

Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma

Baseline characteristics by cohort

Measure	Durvalumab (MEDI4736) Plus Tremelimumab n=32 Participants Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy n=33 Participants Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).	Total n=65 Participants Total of all reporting groups
Age, Continuous	61.3 Years STANDARD_DEVIATION 9.60 • n=5 Participants	61.6 Years STANDARD_DEVIATION 9.54 • n=7 Participants	61.5 Years STANDARD_DEVIATION 9.49 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	33 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	22 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)

Population: The FAS included all randomised patients.

ORR was defined as the percentage of patients with at least one visit response of confirmed complete response (CR) or partial response (PR). CR was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have had reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of TLs, taking as reference the baseline sum of diameters. A confirmed response meant that a response of CR/PR was recorded at 1 visit and confirmed by repeat imaging, preferably at the next regularly scheduled imaging visit and not less than 4 weeks after the visit when response was first observed with no evidence of progression between the initial and CR/PR confirmation visits. Results are reported as percentage of patients with a confirmed response and percentage of patients with confirmed or unconfirmed responses (i.e., including single visit responses).

Outcome measures

Measure	Durvalumab (MEDI4736) Plus Tremelimumab n=32 Participants Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy n=33 Participants Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
Objective Response Rate (ORR) in All Patients Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Confirmed responses only	3.1 Percentage of participants Interval 0.08 to 16.22	0 Percentage of participants Interval 0.0 to 10.58
Objective Response Rate (ORR) in All Patients Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Confirmed and unconfirmed responses	3.1 Percentage of participants Interval 0.08 to 16.22	6.1 Percentage of participants Interval 0.74 to 20.23

SECONDARY outcome

Timeframe: From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)

Population: The FAS included all randomised patients.

PFS was defined as the time from the date of randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient had withdrawn from randomised therapy or had received another anti-cancer therapy prior to progression. Results are reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.

Outcome measures

Measure	Durvalumab (MEDI4736) Plus Tremelimumab n=32 Participants Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy n=33 Participants Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
Progression-free Survival (PFS) Using Investigator Assessments According to RECIST 1.1	1.5 Months Interval 1.2 to 1.5	1.5 Months Interval 1.3 to 1.5

SECONDARY outcome

Timeframe: From date of first infusion until confirmed disease progression or death (up to 3 months and 6 months)

Population: The FAS included all randomised patients.

PFS was defined as the time from the date of randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient had withdrawn from randomised therapy or had received another anti-cancer therapy prior to progression. PFS rates were calculated using Kaplan-Meier estimates of the cumulative probability of PFS. The PFS rate at 3 months and 6 months was equivalent to the percentage of patients with PFS after 3 months and 6 months, respectively.

Outcome measures

Measure	Durvalumab (MEDI4736) Plus Tremelimumab n=32 Participants Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy n=33 Participants Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
PFS Rate at 3 Months and at 6 Months PFS rate at 3 months	9.4 Percentage of participants Interval 2.4 to 22.3	10.9 Percentage of participants Interval 3.0 to 24.7
PFS Rate at 3 Months and at 6 Months PFS rate at 6 months	9.4 Percentage of participants Interval 2.4 to 22.3	3.6 Percentage of participants Interval 0.3 to 15.4

SECONDARY outcome

Timeframe: From date of first infusion until death (up to approximately 18 months for the data analysis cut-off)

Population: The FAS included all randomised patients.

OS was defined as the time from the date of randomisation until death due to any cause. Results are reported as median OS, calculated using the Kaplan-Meier technique.

Outcome measures

Measure	Durvalumab (MEDI4736) Plus Tremelimumab n=32 Participants Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy n=33 Participants Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
Overall Survival (OS)	3.1 Months Interval 2.2 to 6.1	3.6 Months Interval 2.7 to 6.1

SECONDARY outcome

Timeframe: From date of first infusion until death (up to 6 months and 12 months)

Population: The FAS included all randomised patients.

OS was defined as the time from the date of randomisation until death due to any cause. OS rates were calculated using Kaplan-Meier estimates of the cumulative probability of survival at each indicated time period. The OS rate at 6 months and 12 months was equivalent to the percentage of patients with OS after 6 months and 12 months, respectively.

Outcome measures

Measure	Durvalumab (MEDI4736) Plus Tremelimumab n=32 Participants Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy n=33 Participants Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
Survival Status, Presented as OS Rate, at 6 Months and at 12 Months Survival rate at 6 months	36.2 Percentage of participants Interval 20.0 to 52.7	34.9 Percentage of participants Interval 19.2 to 51.1
Survival Status, Presented as OS Rate, at 6 Months and at 12 Months Survival rate at 12 months	8.8 Percentage of participants Interval 1.8 to 22.8	6.3 Percentage of participants Interval 1.1 to 18.4

SECONDARY outcome

Timeframe: From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)

Population: The FAS included all randomised patients.

BoR was calculated based on the overall visit responses from each RECIST assessment. It was the best response a patient had following date of first dosing but prior to starting any subsequent cancer therapy and prior to RECIST progression or last evaluable assessment in absence of RECIST progression. Categorisation of BoR was based on RECIST using the following response categories: CR and PR for status of 'Response'; Stable Disease (SD) ≥6 weeks, Progressive Disease (PD) and Not Evaluable (NE) for status of 'Non-response'. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the sum of diameters of TLs taking as reference the smallest sum on study. NE was only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit. Results are reported as number of patients with BoR for each of the indicated categories.

Outcome measures

Measure	Durvalumab (MEDI4736) Plus Tremelimumab n=32 Participants Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy n=33 Participants Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
Best Objective Response (BoR) Using Investigator Assessments According to RECIST 1.1 Response: Total	1 Participants	0 Participants
Best Objective Response (BoR) Using Investigator Assessments According to RECIST 1.1 Response: CR	0 Participants	0 Participants
Best Objective Response (BoR) Using Investigator Assessments According to RECIST 1.1 Response: PR	1 Participants	0 Participants
Best Objective Response (BoR) Using Investigator Assessments According to RECIST 1.1 Non-response: Total	31 Participants	33 Participants
Best Objective Response (BoR) Using Investigator Assessments According to RECIST 1.1 Non-response: Stable disease ≥6 weeks	5 Participants	7 Participants
Best Objective Response (BoR) Using Investigator Assessments According to RECIST 1.1 Non-response: Progression of disease	26 Participants	25 Participants
Best Objective Response (BoR) Using Investigator Assessments According to RECIST 1.1 Non-response: Not evaluable	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From date of first infusion until confirmed disease progression or death (up to 3 months, 6 months and 12 months)

Population: The FAS included all randomised patients.

DCR at 3 months was defined as the percentage of patients who have a BoR of CR or PR in the first 3 months or who have demonstrated SD for a minimum interval of 13 weeks following the start of treatment. DCR at 6 months was defined as the percentage of patients who have a BoR of CR or PR in the first 6 months or who have demonstrated SD for a minimum interval of 26 weeks following the start of treatment. DCR at 12 months was defined as the percentage of patients who have a BoR of CR or PR in the first 12 months or who have demonstrated SD for a minimum interval of 52 weeks following the start of treatment. Results are reported as the percentage of patients with disease control for each of the indicated categories.

Outcome measures

Measure	Durvalumab (MEDI4736) Plus Tremelimumab n=32 Participants Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy n=33 Participants Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
Disease Control Rate (DCR) Using Investigator Assessments According to RECIST 1.1 At 3 months	9.4 Percentage of participants Interval 1.98 to 25.02	6.1 Percentage of participants Interval 0.74 to 20.23
Disease Control Rate (DCR) Using Investigator Assessments According to RECIST 1.1 At 6 months	6.3 Percentage of participants Interval 0.77 to 20.81	0 Percentage of participants Interval 0.0 to 10.58
Disease Control Rate (DCR) Using Investigator Assessments According to RECIST 1.1 At 12 months	3.1 Percentage of participants Interval 0.08 to 16.22	0 Percentage of participants Interval 0.0 to 10.58

SECONDARY outcome

Timeframe: Blood samples were collected pre-dose on Day 1 (Week 0), Week 4, Week 12 and Week 24, post-dose on Day 1, Week 12 and Week 24, and additionally at 3 months after the last dose (follow-up).

Population: The PK analysis set included all patients who received at least 1 dose of IP, and had PK sampling data post-dose without important deviations or events to affect PK (n=64). Only patients with data available at the timepoints of testing were included in the analyses.

To evaluate PK, blood samples were collected pre- and post-dose and durvalumab (MEDI4736) concentrations in serum were determined. On Day 1 of Cycles 1, 4 and 7 (Weeks 0, 12 and 24), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) and post-dose at the end of infusion (within 10 minutes of end of infusion of durvalumab and within 10 minutes of end of infusion of tremelimumab [for patients receiving durvalumab plus tremelimumab]). On Day 1 of Cycle 2 (Week 4), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) only. The 3-month follow-up sample for durvalumab was relative to the respective last dose. Results are reported as mean pre- or post-dose durvalumab concentrations as indicated by the individual categories (1 cycle=4 weeks). Samples below lower limit of quantification were treated as missing in the analyses.

Outcome measures

Measure	Durvalumab (MEDI4736) Plus Tremelimumab n=32 Participants Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy n=32 Participants Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
Pharmacokinetics (PK) of Durvalumab (MEDI4736) Cycle 1, Day 1, pre-infusion (Day 1)	217.338 Micrograms per millilitre (mcg/mL) Standard Deviation 345.4913	—
Pharmacokinetics (PK) of Durvalumab (MEDI4736) Cycle 1, Day 1, post-infusion (Day 1)	566.078 Micrograms per millilitre (mcg/mL) Standard Deviation 151.4199	562.218 Micrograms per millilitre (mcg/mL) Standard Deviation 152.3811
Pharmacokinetics (PK) of Durvalumab (MEDI4736) Cycle 2, Day 1, pre-infusion (Day 29)	100.417 Micrograms per millilitre (mcg/mL) Standard Deviation 39.7229	98.668 Micrograms per millilitre (mcg/mL) Standard Deviation 36.5072
Pharmacokinetics (PK) of Durvalumab (MEDI4736) Cycle 4, Day 1, pre-infusion (Day 85)	236.205 Micrograms per millilitre (mcg/mL) Standard Deviation 98.8964	228.450 Micrograms per millilitre (mcg/mL) Standard Deviation 36.8395
Pharmacokinetics (PK) of Durvalumab (MEDI4736) Cycle 4, Day 1, post-infusion (Day 85)	825.818 Micrograms per millilitre (mcg/mL) Standard Deviation 322.8247	760.456 Micrograms per millilitre (mcg/mL) Standard Deviation 100.6974
Pharmacokinetics (PK) of Durvalumab (MEDI4736) Cycle 7, Day 1, pre-infusion (Day 169)	166.736 Micrograms per millilitre (mcg/mL) Standard Deviation 47.3872	152.706 Micrograms per millilitre (mcg/mL) Standard Deviation NA Data applies to one patient so standard deviation value not applicable.
Pharmacokinetics (PK) of Durvalumab (MEDI4736) Cycle 7, Day 1, post-infusion (Day169)	918.270 Micrograms per millilitre (mcg/mL) Standard Deviation 98.4286	825.578 Micrograms per millilitre (mcg/mL) Standard Deviation NA Data applies to one patient so standard deviation value not applicable.
Pharmacokinetics (PK) of Durvalumab (MEDI4736) 3-month follow-up	38.456 Micrograms per millilitre (mcg/mL) Standard Deviation NA Data applies to one patient so standard deviation value not applicable.	19.684 Micrograms per millilitre (mcg/mL) Standard Deviation 20.2664

SECONDARY outcome

Timeframe: Blood samples were collected pre-dose on Day 1 (Week 0), Week 4 and Week 12, post-dose on Day 1 and Week 12, and additionally at 3 months after the last dose (follow-up).

Population: The PK analysis set included all patients who received at least 1 dose of IP, and had PK sampling data post-dose without important deviations or events to affect PK (n=64). Only patients with data available at the timepoints of testing were included in the analyses.

To evaluate PK, blood samples were collected pre- and post-dose and tremelimumab concentrations in serum were determined. On Day 1 of Cycles 1 and 4 (Weeks 0 and 12), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) and post-dose at the end of infusion (within 10 minutes of end of infusion of tremelimumab). On Day 1 of Cycle 2 (Week 4), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) only. The 3-month follow-up sample for tremelimumab was relative to the respective last dose. Results are reported as mean pre- or post-dose tremelimumab concentrations as indicated by the individual categories (1 cycle=4 weeks). Samples below lower limit of quantification were treated as missing in the analyses.

Outcome measures

Measure	Durvalumab (MEDI4736) Plus Tremelimumab n=32 Participants Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
PK of Tremelimumab Cycle 1, Day 1, pre-infusion (Day 1)	13.114 mcg/mL Standard Deviation 11.7182	—
PK of Tremelimumab Cycle 1, Day 1, post-infusion (Day 1)	24.477 mcg/mL Standard Deviation 6.3516	—
PK of Tremelimumab Cycle 2, Day 1, pre-infusion (Day 29)	4.880 mcg/mL Standard Deviation 2.2623	—
PK of Tremelimumab Cycle 4, Day 1, pre-infusion (Day 85)	8.753 mcg/mL Standard Deviation 4.9962	—
PK of Tremelimumab Cycle 4, Day 1, post-infusion (Day 85)	21.150 mcg/mL Standard Deviation 5.8997	—

SECONDARY outcome

Timeframe: Immunogenicity samples were collected on Day 1 (Week 0), Week 4, Week 12 and Week 24, and additionally at 3 months and 6 months after the last dose (follow-up).

Population: The ADA evaluable set included all patients in the safety analysis set (i.e. those who had received any IP) who had non-missing baseline ADA data and at least 1 non-missing post-baseline ADA result.

ADA prevalence was the proportion of the ADA evaluable set who had an ADA positive result at any point in time, baseline or post-baseline. ADA incidence (treatment-emergent ADA) was the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA positive patients as a proportion of the evaluable patient population. Treatment-boosted ADA was defined as baseline positive ADA titre boosted to a 4-fold or higher level following IP administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Results are reported as number of patients with detectable anti-durvalumab antibodies satisfying each of the indicated categories. Note: 'positive' is denoted by 'pos' in some category titles.

Outcome measures

Measure	Durvalumab (MEDI4736) Plus Tremelimumab n=25 Participants Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy n=24 Participants Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
Presence of Antidrug Antibodies (ADAs) for Durvalumab (MEDI4736) ADA prevalence	1 Participants	5 Participants
Presence of Antidrug Antibodies (ADAs) for Durvalumab (MEDI4736) ADA incidence	0 Participants	3 Participants
Presence of Antidrug Antibodies (ADAs) for Durvalumab (MEDI4736) ADA pos post-baseline and pos at baseline	0 Participants	0 Participants
Presence of Antidrug Antibodies (ADAs) for Durvalumab (MEDI4736) ADA pos post-baseline and not detected at baseline	0 Participants	3 Participants
Presence of Antidrug Antibodies (ADAs) for Durvalumab (MEDI4736) ADA not detected post-baseline and pos at baseline	1 Participants	2 Participants
Presence of Antidrug Antibodies (ADAs) for Durvalumab (MEDI4736) Treatment-boosted ADA	0 Participants	0 Participants
Presence of Antidrug Antibodies (ADAs) for Durvalumab (MEDI4736) Persistent positive	0 Participants	3 Participants
Presence of Antidrug Antibodies (ADAs) for Durvalumab (MEDI4736) Transient positive	0 Participants	0 Participants
Presence of Antidrug Antibodies (ADAs) for Durvalumab (MEDI4736) Never positive	24 Participants	19 Participants

SECONDARY outcome

Timeframe: Immunogenicity samples were collected on Day 1 (Week 0), Week 4 and Week 12, and additionally at 3 months and 6 months after the last dose (follow-up).

Population: The ADA evaluable set included all patients in the safety analysis set (i.e. those who had received any IP) who had non-missing baseline ADA data and at least 1 non-missing post-baseline ADA result.

ADA prevalence was the proportion of the ADA evaluable set who had an ADA positive result at any point in time, baseline or post-baseline. ADA incidence (treatment-emergent ADA) was the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA positive patients as a proportion of the evaluable patient population. Treatment-boosted ADA was defined as baseline positive ADA titre boosted to a 4-fold or higher level following IP administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Results are reported as number of patients with detectable anti- tremelimumab antibodies satisfying each of the indicated categories. Note: 'positive' is denoted by 'pos' in some category titles.

Outcome measures

Measure	Durvalumab (MEDI4736) Plus Tremelimumab n=25 Participants Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
Presence of ADAs for Tremelimumab ADA prevalence	2 Participants	—
Presence of ADAs for Tremelimumab ADA incidence	0 Participants	—
Presence of ADAs for Tremelimumab ADA pos post-baseline and pos at baseline	1 Participants	—
Presence of ADAs for Tremelimumab ADA pos post-baseline and not detected at baseline	0 Participants	—
Presence of ADAs for Tremelimumab ADA not detected post-baseline and pos at baseline	1 Participants	—
Presence of ADAs for Tremelimumab Treatment-boosted ADA	0 Participants	—
Presence of ADAs for Tremelimumab Persistent positive	0 Participants	—
Presence of ADAs for Tremelimumab Transient positive	1 Participants	—
Presence of ADAs for Tremelimumab Never positive	23 Participants	—

Adverse Events

Durvalumab (MEDI4736) Plus Tremelimumab

Serious events: 11 serious events

Other events: 26 other events

Deaths: 19 deaths

Durvalumab (MEDI4736) Monotherapy

Serious events: 9 serious events

Other events: 26 other events

Deaths: 16 deaths

Serious adverse events

Measure	Durvalumab (MEDI4736) Plus Tremelimumab n=32 participants at risk Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy n=32 participants at risk Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
Gastrointestinal disorders Abdominal distension	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Ascites	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Diarrhoea	9.4% 3/32 • Number of events 3 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Haematemesis	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Haematochezia	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Intestinal obstruction	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Large intestine perforation	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Vomiting	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
General disorders Asthenia	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
General disorders Fatigue	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
General disorders Pyrexia	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Hepatobiliary disorders Autoimmune hepatitis	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Hepatobiliary disorders Cholangitis	6.2% 2/32 • Number of events 3 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Infections and infestations Bacteraemia	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Infections and infestations Enterococcal sepsis	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Infections and infestations Infection	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Infections and infestations Sepsis	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders Muscular weakness	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders Myositis	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Renal and urinary disorders Acute kidney injury	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Vascular disorders Embolism	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.

Other adverse events

Measure	Durvalumab (MEDI4736) Plus Tremelimumab n=32 participants at risk Patients in the durvalumab (MEDI4736) plus tremelimumab combination therapy arm received 1.5 g durvalumab and 75 mg tremelimumab via IV infusion q4w over a 16-week treatment period. Patients then continued with durvalumab monotherapy at 1.5 g q4w, beginning at Week 16, 4 weeks after the last dose of combination therapy, up to a total of 9 additional doses, with the final dose at Week 48. For the combination therapy, tremelimumab was administered first; the durvalumab infusion was started approximately 1 hour after the end of the tremelimumab infusion.	Durvalumab (MEDI4736) Monotherapy n=32 participants at risk Patients in the durvalumab (MEDI4736) monotherapy arm received 1.5 g durvalumab via IV infusion q4w over a 48-week treatment period (up to 13 doses).
Endocrine disorders Hypothyroidism	12.5% 4/32 • Number of events 4 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Endocrine disorders Thyroiditis	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Abdominal pain	9.4% 3/32 • Number of events 4 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Ascites	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	9.4% 3/32 • Number of events 3 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Constipation	15.6% 5/32 • Number of events 5 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	21.9% 7/32 • Number of events 7 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Diarrhoea	12.5% 4/32 • Number of events 6 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	15.6% 5/32 • Number of events 7 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Dry mouth	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Dyspepsia	18.8% 6/32 • Number of events 6 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Flatulence	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Nausea	12.5% 4/32 • Number of events 5 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	15.6% 5/32 • Number of events 6 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Gastrointestinal disorders Vomiting	15.6% 5/32 • Number of events 6 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	15.6% 5/32 • Number of events 7 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
General disorders Asthenia	9.4% 3/32 • Number of events 3 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	12.5% 4/32 • Number of events 4 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
General disorders Fatigue	18.8% 6/32 • Number of events 6 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	28.1% 9/32 • Number of events 10 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
General disorders Feeling cold	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	9.4% 3/32 • Number of events 3 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
General disorders Oedema peripheral	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	9.4% 3/32 • Number of events 3 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
General disorders Pyrexia	18.8% 6/32 • Number of events 10 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 4 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Hepatobiliary disorders Cholangitis	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Infections and infestations Gingivitis	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Investigations Weight decreased	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Metabolism and nutrition disorders Decreased appetite	25.0% 8/32 • Number of events 8 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	25.0% 8/32 • Number of events 9 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Metabolism and nutrition disorders Hypophagia	9.4% 3/32 • Number of events 3 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders Back pain	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders Myalgia	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	9.4% 3/32 • Number of events 5 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	9.4% 3/32 • Number of events 6 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Nervous system disorders Dizziness	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Nervous system disorders Headache	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Psychiatric disorders Anxiety	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Psychiatric disorders Confusional state	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Psychiatric disorders Insomnia	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	9.4% 3/32 • Number of events 3 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders Cough	9.4% 3/32 • Number of events 4 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.4% 3/32 • Number of events 3 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	12.5% 4/32 • Number of events 4 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Skin and subcutaneous tissue disorders Dry skin	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Skin and subcutaneous tissue disorders Pruritus	12.5% 4/32 • Number of events 4 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	9.4% 3/32 • Number of events 4 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Skin and subcutaneous tissue disorders Rash	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	9.4% 3/32 • Number of events 3 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	0.00% 0/32 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Vascular disorders Deep vein thrombosis	9.4% 3/32 • Number of events 3 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	3.1% 1/32 • Number of events 1 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.
Vascular disorders Hypotension	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.	6.2% 2/32 • Number of events 2 • Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months. TEAE definition: onset date ≥ first dose of IP (or pre-treatment AEs increasing in severity ≥ first dose) and ≤ the last dose of IP + 90 days or ≤ start date of subsequent therapy (whichever occurred first). All-cause mortality definition: death due to any cause (including disease progression of pancreatic cancer) up to 90 days after last dose of IP or until start of subsequent therapy, whichever occurred first.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: +1 301-398-0000

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place