Trial Outcomes & Findings for Phase Ib/II Study of MEDI4736 Evaluated in Different Combinations in Metastatic Pancreatic Ductal Carcinoma (NCT NCT02583477)

NCT ID: NCT02583477

Last Updated: 2019-08-14

Results Overview

DLT period was defined as first treatment cycle for Cohort 1, and first dose of AZD5069 and MEDI4736 to end of Cycle 1 or until a participant experienced a DLT, whichever occurs first for Cohort 2. A DLT was defined as any of below listed laboratory abnormalities or adverse events (AE) related to MEDI4736 collected during DLT period. * Liver transaminase elevation \>= 5× but \<= 8× upper limit of normal (ULN) that doesn't resolve to Grade 2 within 5 days * Transaminase elevation \> 8× ULN or total bilirubin \> 5× ULN * Any Grade 4 immune-related AE (irAE) not attributed to local tumor response, Grade \>=3 colitis, Grade \>=2 pneumonitis that doesn't resolve to \<= Grade 1 within 7 days, Grade 3 irAE, that doesn't resolve to Grade \<=1 or baseline status within 14 days * Any Grade \>=3 non-irAE toxicity that doesn't resolve to Grade \<=1 or baseline status within 14 days A DLT was defined as any Grade 3 or worse AE related to AZD5069 that occurs from first dose of AZD5069 up to end of DLT period.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: Cohort 1: From time of first dose of MEDI4736 on Day 1 up to Day 28 of Cycle 1 and Cohort 2: From time of first dose of AZD5069 and MEDI4736 on Day 1 up to Day 28 of Cycle 1 or until a participant experiences a DLT, whichever occurs first.
• Results posted on: 2019-08-14

Participant Flow

This study consisted of 2 independent cohorts, each of which ran at separate times between 25 March 2016 and 09 July 2018. In Cohort 1, participants were recruited from 1 center in the United States; in Cohort 2, participants were recruited from 6 centers in the United Kingdom.

Participants underwent screening evaluations to determine eligibility within 4 weeks (28 days) prior to first administration of the Investigational Product (IP). A total of 27 participants (3 in Cohort 1 and 24 in Cohort 2) were assigned to treatment and 23 were treated. Only treated participants are included in the participant flow.

Participant milestones

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) Participants with metastatic pancreatic ductal adenocarcinoma (PDAC) who were treatment naive received MEDI4736 1.5 gram (g) intravenous (IV) infusion on Day 1 of each 28-day cycle (q4w). Participants also received nab-paclitaxel 125 milligram per meter square (mg/m\^2) IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed progressive disease (PD) unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally twice daily (bid). The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Overall Study STARTED	3	20
Overall Study Received Treatment	3	20
Overall Study Completed Treatment	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	20

Reasons for withdrawal

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) Participants with metastatic pancreatic ductal adenocarcinoma (PDAC) who were treatment naive received MEDI4736 1.5 gram (g) intravenous (IV) infusion on Day 1 of each 28-day cycle (q4w). Participants also received nab-paclitaxel 125 milligram per meter square (mg/m\^2) IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed progressive disease (PD) unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally twice daily (bid). The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Overall Study Adverse Event	0	2
Overall Study Death	1	16
Overall Study Study terminated	2	2

Baseline Characteristics

Phase Ib/II Study of MEDI4736 Evaluated in Different Combinations in Metastatic Pancreatic Ductal Carcinoma

Baseline characteristics by cohort

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=3 Participants Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) n=20 Participants Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Total n=23 Participants Total of all reporting groups
Age, Customized <50 years	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Age, Customized >=50 - <65 years	1 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants
Age, Customized >=65 - <75 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants	18 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Cohort 1: From time of first dose of MEDI4736 on Day 1 up to Day 28 of Cycle 1 and Cohort 2: From time of first dose of AZD5069 and MEDI4736 on Day 1 up to Day 28 of Cycle 1 or until a participant experiences a DLT, whichever occurs first.

Population: For Cohort 1: Participants who completed DLT evaluation period and/or discontinued study treatment early due to a DLT and who have not missed \>=2 infusions of gemcitabine. For Cohort 2: Participants who received 50% of planned doses of AZD5069 during DLT period as well as MEDI4736 infusion and remained active on study at end of Day 28 of Cycle 1.

DLT period was defined as first treatment cycle for Cohort 1, and first dose of AZD5069 and MEDI4736 to end of Cycle 1 or until a participant experienced a DLT, whichever occurs first for Cohort 2.

A DLT was defined as any of below listed laboratory abnormalities or adverse events (AE) related to MEDI4736 collected during DLT period.

• Liver transaminase elevation >= 5× but <= 8× upper limit of normal (ULN) that doesn't resolve to Grade 2 within 5 days
• Transaminase elevation > 8× ULN or total bilirubin > 5× ULN
• Any Grade 4 immune-related AE (irAE) not attributed to local tumor response, Grade >=3 colitis, Grade >=2 pneumonitis that doesn't resolve to <= Grade 1 within 7 days, Grade 3 irAE, that doesn't resolve to Grade <=1 or baseline status within 14 days
• Any Grade >=3 non-irAE toxicity that doesn't resolve to Grade <=1 or baseline status within 14 days A DLT was defined as any Grade 3 or worse AE related to AZD5069 that occurs from first dose of AZD5069 up to end of DLT period.

Outcome measures

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=3 Participants Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) n=12 Participants Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Number of Participants With Dose-Limiting Toxicities (DLT)	0 Participants	4 Participants

PRIMARY outcome

Timeframe: From first dose of study treatment administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months.

Population: The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.

An AE is the development of an undesirable medical condition or deterioration of a pre-existing medical condition following or during exposure to study treatment, whether or not considered causally related to study treatment. An undesirable medical condition can be symptoms, signs or abnormal results of an investigation. A serious AE (SAE) is an AE that fulfills one or more following criteria: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions, congenital abnormality or birth defect, and an important medical event that may jeopardize participant or may require medical intervention to prevent one of outcomes listed above. AEs leading to discontinuation of study treatment were those with action taken was 'Drug Permanently Discontinued' for any study treatment. Only treatment emergent AEs were presented.

Outcome measures

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=3 Participants Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) n=20 Participants Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Number of Participants With AEs Any AE	3 Participants	20 Participants
Number of Participants With AEs Any AE causally related to treatment (CRT)	3 Participants	14 Participants
Number of Participants With AEs Any AE of CTCAE Grade 3 or higher	3 Participants	18 Participants
Number of Participants With AEs Any AE of CTCAE Grade 3 or higher CRT	3 Participants	10 Participants
Number of Participants With AEs Any AE leading discontinuation of study treatment	2 Participants	3 Participants
Number of Participants With AEs Any AE with outcome of death	1 Participants	4 Participants
Number of Participants With AEs Any AE with outcome of death CRT	1 Participants	0 Participants
Number of Participants With AEs Any SAE	1 Participants	16 Participants
Number of Participants With AEs Any SAE CRT	1 Participants	8 Participants

PRIMARY outcome

Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), every 6 weeks +/-7 days for first 48 weeks, then every 12 weeks +/-7 days thereafter until confirmed objective disease progression. Up to approximately 30 months.

Population: The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.

ORR is defined as the percentage of participants with a confirmed overall response of complete response (CR) or partial response (PR). A confirmed response of CR/PR means that a response of CR/PR is 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 the response was first observed with no evidence of progression between the initial and CR/PR confirmation visit. CR is defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of TLs, taking as reference the baseline sum of diameters as long as criteria for PD were not met. ORR was determined using Investigator assessments according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).

Outcome measures

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=18 Participants Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Objective Response Rate (ORR) in Cohort 2	5.6 percentage of participants Interval 0.58 to 19.95	—

SECONDARY outcome

Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), every 6 weeks +/-7 days for first 48 weeks, then every 12 weeks +/-7 days thereafter until confirmed objective disease progression. Up to approximately 30 months.

Population: The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation. Participants with confirmed response were evaluated, only one participant showed response.

DoR was defined as the time from the first documentation of CR/PR (which is subsequently confirmed) until the date of progression/death, or the last evaluable RECIST assessment for participants that did not progress or did progress after 2 missed visits of the last evaluable assessment (or first dose). PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. DoR was determined using Investigator assessments according to RECIST v1.1 and was calculated using the Kaplan-Meier technique.

Outcome measures

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=1 Participants Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Duration of Response (DoR) in Cohort 2	18.29 weeks Interval 18.29 to 18.29	—

SECONDARY outcome

Timeframe: RECIST assessments were performed at baseline (within 28 days before start of study treatment) and every 6 weeks +/- 7 days for first 48 weeks up to 6 months and 12 months

Population: The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.

DCR at 6 months is defined as the percentage of participants who had a best objective response (BoR) of CR or PR in the first 6 months (i.e. 24+1=25 weeks to allow for a late assessment within the assessment window) or who had demonstrated stable disease (SD) for a minimum interval of 24 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. DCR at 12 months is defined as the percentage of participants who had a BoR of CR or PR in the first 12 months (i.e. 48+1=49 weeks to allow for a late assessment within the assessment window) or who had demonstrated SD for a minimum interval of 48 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 329 days) following the start of treatment. DCR was determined using Investigator assessments according to RECIST v1.1.

Outcome measures

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=18 Participants Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Disease Control Rate (DCR) in Cohort 2 At 6 months	11.1 percentage of participants	—
Disease Control Rate (DCR) in Cohort 2 At 12 months	5.6 percentage of participants	—

SECONDARY outcome

Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), every 6 weeks +/-7 days for first 48 weeks, then every 12 weeks +/-7 days thereafter until confirmed objective disease progression. Up to approximately 30 months.

Population: The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.

PFS is defined as the time from the date of first dose until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraws from allocated therapy or receives another anticancer therapy prior to progression. PFS was determined using Investigator assessments according to RECIST v1.1 and calculated using the Kaplan-Meier technique.

Outcome measures

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=18 Participants Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Median Progression-Free Survival (PFS) in Cohort 2	1.6 months Interval 1.29 to 1.68	—

SECONDARY outcome

Timeframe: RECIST assessments were performed at baseline (within 28 days before start of study treatment) and every 6 weeks +/- 7 days up to 3 months

Population: The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.

The PFS rate was defined as percentage of participants alive and progression-free after 3 months. The PFS3 was calculated using Kaplan-Meier estimates. Tumor progression was determined based on Investigator assessment and RECIST v1.1.

Outcome measures

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=18 Participants Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Progression-Free Survival Rate at 3 Months (PFS3) in Cohort 2	11.1 percentage of participants Interval 3.91 to 22.55	—

SECONDARY outcome

Timeframe: RECIST assessments were performed at baseline (within 28 days before start of study treatment) and every 6 weeks +/- 7 days up to 6 months

Population: The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.

The PFS6 was defined as percentage of participants alive and progression-free after 6 months. The PFS6 was calculated using Kaplan-Meier estimates. Tumor progression was determined based on Investigator assessment and RECIST v1.1.

Outcome measures

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=18 Participants Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Progression-Free Survival Rate at 6 Months (PFS6) in Cohort 2	11.1 percentage of participants Interval 3.91 to 22.55	—

SECONDARY outcome

Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), every 6 weeks +/-7 days for first 48 weeks, then every 12 weeks +/-7 days thereafter until confirmed objective disease progression. Up to approximately 30 months.

Population: The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.

OS is defined as the time from the date of first dose until death due to any cause (i.e. date of death or censoring - date of first dose + 1). OS was calculated using the Kaplan-Meier technique. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive (censored at end of study).

Outcome measures

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=18 Participants Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Median Overall Survival (OS) in Cohort 2	2.8 months Interval 1.68 to 3.79	—

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to 6 months

Population: The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.

OS6 is defined as percentage of participants alive at 6 months from first dose of study treatment. OS6 was calculated using the Kaplan-Meier estimate of OS at 6 months.

Outcome measures

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=18 Participants Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Overall Survival at 6 Months (OS6) in Cohort 2	22.2 percentage of participants Interval 11.19 to 35.59	—

SECONDARY outcome

Timeframe: From first dose of study treatment (Day 1) up to 12 months

Population: The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.

OS12 is defined as percentage of participants alive at 12 months from first dose of study treatment. OS12 was calculated using the Kaplan-Meier estimate of OS at 12 months.

Outcome measures

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=18 Participants Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Overall Survival at 12 Months (OS12) in Cohort 2	14.8 percentage of participants Interval 5.74 to 27.92	—

SECONDARY outcome

Timeframe: On Day 1 of Cycles 1, 2, 3, 4, and 7; At months 3 and 6 after last dose

Population: The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.

Samples were measured for the presence of ADAs and ADA-neutralizing antibodies for MEDI4736 using validated assays. Persistently positive is defined as positive at >=2 post-baseline assessments or positive at the last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. NAB = neutralizing antibody.

Outcome measures

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=20 Participants Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Number of Participants With Anti-Drug Antibody (ADAs) for MEDI4736 in Cohort 2 Positive at any visit	3 Participants	—
Number of Participants With Anti-Drug Antibody (ADAs) for MEDI4736 in Cohort 2 Both baseline and post-baseline positive	0 Participants	—
Number of Participants With Anti-Drug Antibody (ADAs) for MEDI4736 in Cohort 2 Only post-baseline positive	1 Participants	—
Number of Participants With Anti-Drug Antibody (ADAs) for MEDI4736 in Cohort 2 Only baseline positive	2 Participants	—
Number of Participants With Anti-Drug Antibody (ADAs) for MEDI4736 in Cohort 2 ADA persistently positive	0 Participants	—
Number of Participants With Anti-Drug Antibody (ADAs) for MEDI4736 in Cohort 2 ADA transiently positive	1 Participants	—
Number of Participants With Anti-Drug Antibody (ADAs) for MEDI4736 in Cohort 2 ADA positive participants who are NAB positive	0 Participants	—

SECONDARY outcome

Timeframe: Predose (within 60 minutes prior to treatment with any IP) on Day 1 of Cycles 1, 2, 3, 4, and 7; and post infusion (within 10 minutes after end of MEDI4736 infusion) on Day 1 of Cycles 1 and 7

Population: The Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of IP per protocol for whom any post-dose data were available and who did not violate or deviate from the protocol in ways that would significantly affect the PK analyses.

Mean peak and trough plasma concentrations of MEDI4736 are presented.

Outcome measures

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=20 Participants Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Mean Plasma Concentrations of MEDI4736 in Cohort 2 Cycle 1 Day 1: Predose	1444.730 nanograms per milliliter Standard Deviation 1010.7667	—
Mean Plasma Concentrations of MEDI4736 in Cohort 2 Cycle 1 Day 1: Post infusion	339342.229 nanograms per milliliter Standard Deviation 95923.6405	—
Mean Plasma Concentrations of MEDI4736 in Cohort 2 Cycle 2 Day 1: Predose	56773.555 nanograms per milliliter Standard Deviation 17716.8788	—
Mean Plasma Concentrations of MEDI4736 in Cohort 2 Cycle 3 Day 1: Predose	63655.840 nanograms per milliliter Standard Deviation 26425.8402	—
Mean Plasma Concentrations of MEDI4736 in Cohort 2 Cycle 4 Day 1: Predose	69325.233 nanograms per milliliter Standard Deviation 22750.3387	—
Mean Plasma Concentrations of MEDI4736 in Cohort 2 Cycle 7 Day 1: Predose	79687.820 nanograms per milliliter Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—
Mean Plasma Concentrations of MEDI4736 in Cohort 2 Cycle 7 Day 1: Post infusion	435297.610 nanograms per milliliter Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—

SECONDARY outcome

Timeframe: Predose (within 60 minutes prior to treatment with any IP) on Day 1 of Cycles 1, 2, 3, 4, and 7; and postdose (within 10 minutes after end of MEDI4736 infusion) on Day 1 of Cycles 1, 2, and 7

Population: The PK analysis set included all participants who received at least 1 dose of IP per protocol for whom any post-dose data were available and who did not violate or deviate from the protocol in ways that would significantly affect the PK analyses.

Mean peak and trough plasma concentration of AZD5069 are presented. Concentration of AZD5069 was calculated by plasma concentration-time profile.

Outcome measures

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=20 Participants Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Mean Plasma Concentrations of AZD5069 in Cohort 2 Cycle 1 Day 1: Predose	10.60 nanomoles per liter Standard Deviation 42.933	—
Mean Plasma Concentrations of AZD5069 in Cohort 2 Cycle 1 Day 1: Postdose	2236.29 nanomoles per liter Standard Deviation 1678.496	—
Mean Plasma Concentrations of AZD5069 in Cohort 2 Cycle 2 Day 1: Predose	1829.36 nanomoles per liter Standard Deviation 1473.533	—
Mean Plasma Concentrations of AZD5069 in Cohort 2 Cycle 2 Day 1: Postdose	24.40 nanomoles per liter Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—
Mean Plasma Concentrations of AZD5069 in Cohort 2 Cycle 3 Day 1: Predose	502.48 nanomoles per liter Standard Deviation 601.914	—
Mean Plasma Concentrations of AZD5069 in Cohort 2 Cycle 4 Day 1: Predose	1345.00 nanomoles per liter Standard Deviation 1068.666	—
Mean Plasma Concentrations of AZD5069 in Cohort 2 Cycle 7 Day 1: Predose	1200.00 nanomoles per liter Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—
Mean Plasma Concentrations of AZD5069 in Cohort 2 Cycle 7 Day 1: Postdose	7540.00 nanomoles per liter Standard Deviation NA Standard deviation cannot be calculated when only one participant analyzed.	—

Adverse Events

Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Cohort 2 (MEDI4736 + AZD5069)

Serious events: 16 serious events

Other events: 20 other events

Deaths: 16 deaths

Serious adverse events

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=3 participants at risk Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) n=20 participants at risk Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Enterocolitis	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Nausea	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Obstruction gastric	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
General disorders General physical health deterioration	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
General disorders Pyrexia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Hepatobiliary disorders Cholangitis	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Hepatobiliary disorders Drug-induced liver injury	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	0.00% 0/20 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Hepatobiliary disorders Hepatic failure	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	0.00% 0/20 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Hepatobiliary disorders Hepatitis	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Infections and infestations Biliary sepsis	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Infections and infestations Lower respiratory tract infection	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Infections and infestations Neutropenic sepsis	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Infections and infestations Pneumonia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Infections and infestations Streptococcal sepsis	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Infections and infestations Viral infection	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Investigations Neutrophil count decreased	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	0.00% 0/20 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Nervous system disorders Ischaemic stroke	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Pneumonitis	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Vascular disorders Embolism	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.

Other adverse events

Measure	Cohort 1 (MEDI4736 + Nab-paclitaxel + Gemcitabine) n=3 participants at risk Participants with metastatic PDAC who were treatment naive received MEDI4736 1.5 g IV infusion q4w. Participants also received nab-paclitaxel 125 mg/m\^2 IV infusion followed by gemcitabine 1000 mg/m\^2 IV infusion on Days 1, 8, and 15 of each 28-day cycle. Treatment continued until either confirmed PD unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Cohort 2 (MEDI4736 + AZD5069) n=20 participants at risk Participants with metastatic PDAC with progression on the indicated types of chemotherapy received MEDI4736 1.5 g IV infusion q4w. Participants also received AZD5069 orally bid. The starting dose of 80 mg orally bid (with dose reductions to 40 mg or 20 mg for toxicity allowable). Treatment continued until either confirmed PD, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Blood and lymphatic system disorders Leukopenia	33.3% 1/3 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	0.00% 0/20 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Blood and lymphatic system disorders Neutropenia	66.7% 2/3 • Number of events 6 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Cardiac disorders Tachycardia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Cardiac disorders Ventricular extrasystoles	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Endocrine disorders Hypothyroidism	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Eye disorders Blindness unilateral	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	30.0% 6/20 • Number of events 7 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	15.0% 3/20 • Number of events 3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Aptyalism	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Ascites	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Colitis	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	0.00% 0/20 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Constipation	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	20.0% 4/20 • Number of events 5 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Diarrhoea	66.7% 2/3 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	20.0% 4/20 • Number of events 7 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	15.0% 3/20 • Number of events 3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Glossodynia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Melaena	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	40.0% 8/20 • Number of events 10 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Parotid gland enlargement	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Peptic ulcer	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Rectal discharge	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Steatorrhoea	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	25.0% 5/20 • Number of events 5 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Tongue coated	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 10 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
General disorders Administration site mass	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
General disorders Chills	33.3% 1/3 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	0.00% 0/20 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
General disorders Fatigue	66.7% 2/3 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	50.0% 10/20 • Number of events 11 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
General disorders Oedema peripheral	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
General disorders Pain	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
General disorders Peripheral swelling	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
General disorders Pyrexia	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 5 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Infections and infestations Cellulitis	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Infections and infestations Escherichia urinary tract infection	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Infections and infestations Lower respiratory tract infection viral	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Infections and infestations Nasopharyngitis	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Infections and infestations Oral candidiasis	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	25.0% 5/20 • Number of events 5 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Infections and infestations Pneumonia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Infections and infestations Skin infection	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Infections and infestations Urinary tract infection	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	0.00% 0/20 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	15.0% 3/20 • Number of events 3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Injury, poisoning and procedural complications Skin wound	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Investigations Blood bicarbonate decreased	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 4 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Investigations Blood creatinine increased	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	0.00% 0/20 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Investigations Blood glucose increased	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Investigations Body temperature increased	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Investigations Citrobacter test positive	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Investigations Lymphocyte count decreased	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Investigations Neutrophil count decreased	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Investigations Prothrombin time prolonged	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Investigations Weight decreased	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	15.0% 3/20 • Number of events 4 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	35.0% 7/20 • Number of events 8 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Metabolism and nutrition disorders Diabetes mellitus	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	0.00% 0/20 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 5 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Metabolism and nutrition disorders Hypocalcaemia	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	0.00% 0/20 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Metabolism and nutrition disorders Hyponatraemia	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Muscle spasms	33.3% 1/3 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	0.00% 0/20 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	15.0% 3/20 • Number of events 3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Nervous system disorders Disturbance in attention	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Nervous system disorders Dizziness	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Nervous system disorders Dysgeusia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Nervous system disorders Headache	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	0.00% 0/20 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Nervous system disorders Lethargy	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	15.0% 3/20 • Number of events 3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Nervous system disorders Paraesthesia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Nervous system disorders Somnolence	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Psychiatric disorders Anxiety	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Psychiatric disorders Confusional state	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Psychiatric disorders Depressed mood	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Psychiatric disorders Depression	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Psychiatric disorders Insomnia	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	0.00% 0/20 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Renal and urinary disorders Haematuria	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Renal and urinary disorders Polyuria	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	15.0% 3/20 • Number of events 3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Alopecia	66.7% 2/3 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	10.0% 2/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Pruritus	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	0.00% 0/20 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	0.00% 0/20 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Vasculitic rash	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 2 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.
Vascular disorders Vena cava thrombosis	0.00% 0/3 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.	5.0% 1/20 • Number of events 1 • From initial IP administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months. The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: +1 302 885 1180

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

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