Trial Outcomes & Findings for Investigating Safety, Tolerability and Efficacy of AZD5363 When Combined With Paclitaxel in Breast Cancer Patients (NCT NCT01625286)

Last Updated: 2023-01-18

Results Overview

An Adverse Event (AE) or laboratory abnormality considered to be related to study drug, that starts at any time during the DLT evaluation period (Cycle 1) and is dose limiting

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

148 participants

Primary outcome timeframe

During Part A DLT evaluation period (Cycle 1, up to 28 days)

Results posted on

2023-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Part A Schedule 1 560 mg bd Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 640 mg bd Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 360 mg bd Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 400 mg bd Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 480 mg bd Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part B AZD5363 (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Part B Placebo (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
Overall Study STARTED	12	8	5	7	6	54	56
Overall Study Received AZD5363/Placebo Treatment	12	8	5	7	6	54	55
Overall Study Did Not Receive AZD5363/Placebo Trt	0	0	0	0	0	0	1
Overall Study COMPLETED	6	4	0	0	0	40	37
Overall Study NOT COMPLETED	6	4	5	7	6	14	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A Schedule 1 560 mg bd Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 640 mg bd Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 360 mg bd Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 400 mg bd Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 480 mg bd Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part B AZD5363 (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Part B Placebo (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
Overall Study Adverse Event	0	0	0	0	1	2	1
Overall Study Death	0	0	1	1	0	11	16
Overall Study Withdrawal by Subject	0	1	0	1	0	0	1
Overall Study Any reason not specifically recorded	0	0	0	0	0	1	0
Overall Study Progressive disease	6	3	4	5	5	0	0
Overall Study Lost to Follow-up	0	0	0	0	0	0	1

Baseline Characteristics

For Part A Schedule 2 400 mg bd, there were no participants aged \>=65

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A Schedule 1 560 mg bd n=12 Participants Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 640 mg bd n=8 Participants Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 360 mg bd n=5 Participants Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 400 mg bd n=7 Participants Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 480 mg bd n=6 Participants Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part B AZD5363 n=54 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Part B Placebo n=56 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Total n=148 Participants Total of all reporting groups
Age, Continuous	52.2 Years STANDARD_DEVIATION 9.92 • n=5 Participants	58.8 Years STANDARD_DEVIATION 12.78 • n=7 Participants	56.6 Years STANDARD_DEVIATION 10.26 • n=5 Participants	47.1 Years STANDARD_DEVIATION 9.41 • n=4 Participants	49.8 Years STANDARD_DEVIATION 13.12 • n=21 Participants	54.3 Years STANDARD_DEVIATION 10.01 • n=10 Participants	57.4 Years STANDARD_DEVIATION 11.38 • n=115 Participants	58.8 Years STANDARD_DEVIATION 11.24 • n=6 Participants
Age, Customized <50	5 Participants n=5 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	3 Participants n=7 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	1 Participants n=5 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	4 Participants n=4 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	2 Participants n=21 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	19 Participants n=10 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	16 Participants n=115 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	50 Participants n=6 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65
Age, Customized >=50 - <65	5 Participants n=5 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	2 Participants n=7 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	3 Participants n=5 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	3 Participants n=4 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	3 Participants n=21 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	24 Participants n=10 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	26 Participants n=115 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	66 Participants n=6 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65
Age, Customized >=65	2 Participants n=5 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	3 Participants n=7 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	1 Participants n=5 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	0 Participants n=4 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	1 Participants n=21 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	11 Participants n=10 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	14 Participants n=115 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65	32 Participants n=6 Participants • For Part A Schedule 2 400 mg bd, there were no participants aged \>=65
Sex: Female, Male Female	12 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	6 Participants n=21 Participants	54 Participants n=10 Participants	56 Participants n=115 Participants	148 Participants n=6 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	12 Participants n=10 Participants	15 Participants n=115 Participants	28 Participants n=6 Participants
Race/Ethnicity, Customized Black Or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants
Race/Ethnicity, Customized White	10 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	6 Participants n=21 Participants	24 Participants n=10 Participants	18 Participants n=115 Participants	78 Participants n=6 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	15 Participants n=10 Participants	16 Participants n=115 Participants	31 Participants n=6 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	7 Participants n=115 Participants	10 Participants n=6 Participants

PRIMARY outcome

Timeframe: During Part A DLT evaluation period (Cycle 1, up to 28 days)

Population: All Part A patients who either completed the DLT evaluation period with at least 80% of specified dose (of AZD5363 or paxlitaxel) or who experienced a DLT. DLT events were not assessed for Part B participants.

An Adverse Event (AE) or laboratory abnormality considered to be related to study drug, that starts at any time during the DLT evaluation period (Cycle 1) and is dose limiting

Outcome measures

Outcome measures
Measure	Part A Schedule 2 480 mg bd n=6 Participants Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 400 mg bd n=7 Participants Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 560 mg bd n=11 Participants Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 640 mg bd n=6 Participants Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 360 mg bd n=5 Participants Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part B AZD5363 (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Part B Placebo (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
Dose-limiting Toxicity (DLT) Events - Part A	2 participants	0 participants	0 participants	2 participants	0 participants	—	—

PRIMARY outcome

Timeframe: From randomisation date to date of objective disease progression or death (by any cause) whichever came first, assessed every 12 wks (median total treatment duration AZD5363=325.5 days; Placebo=245 days)

Population: Intent to Treat (ITT), all randomised patients

Time from randomisation to date of objective disease progression or death (by any cause in the absence of progression). Progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a \>= 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on the study, and an absolute increase of \>=5mm, or progression of non-target lesions or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Part A Schedule 2 480 mg bd Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 400 mg bd Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 560 mg bd Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 640 mg bd Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 360 mg bd Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part B AZD5363 n=54 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Part B Placebo n=56 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
Progression Free Survival (PFS) - Part B	—	—	—	—	—	10.9 Months Interval 8.3 to 12.4	8.4 Months Interval 8.2 to 10.8

SECONDARY outcome

Timeframe: RECIST tumour assessments every 12 weeks

Population: Part A:Full Analysis Set (FAS) Part B: Intent to Treat (ITT)

Percentage change from baseline to week 12 in sum of longest diameters of target lesions as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). Based on patients with measurable disease who had sufficient data available to either calculate or impute a change at 12 weeks

Outcome measures

Outcome measures
Measure	Part A Schedule 2 480 mg bd n=4 Participants Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 400 mg bd n=5 Participants Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 560 mg bd n=10 Participants Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 640 mg bd n=7 Participants Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 360 mg bd n=5 Participants Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part B AZD5363 n=53 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Part B Placebo n=55 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
Change in Tumour Size at 12 Weeks	-10.2 % change from baseline Standard Deviation 24.84	-18.3 % change from baseline Standard Deviation 37.74	-11.0 % change from baseline Standard Deviation 33.42	-15.7 % change from baseline Standard Deviation 13.33	-19.1 % change from baseline Standard Deviation 17.73	-34.2 % change from baseline Standard Deviation 28.91	-25.4 % change from baseline Standard Deviation 35.87

SECONDARY outcome

Timeframe: RECIST tumour assessments every 12 weeks

Population: Part A:Full Analysis Set (FAS) Part B: Intent to Treat (ITT)

Percentage of patients who have at least one visit response of Complete Response or Partial Response prior to any evidence of progression at week 12 as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm; Objective Response Rate (ORR) = CR + PR

Outcome measures

Outcome measures
Measure	Part A Schedule 2 480 mg bd n=6 Participants Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 400 mg bd n=7 Participants Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 560 mg bd n=12 Participants Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 640 mg bd n=8 Participants Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 360 mg bd n=5 Participants Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part B AZD5363 n=54 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Part B Placebo n=56 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
Objective Response Rate (ORR) at Week 12	0 % of participants	0 % of participants	41.7 % of participants	12.5 % of participants	0 % of participants	50 % of participants	42.9 % of participants

SECONDARY outcome

Timeframe: From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).

Number of patients, taking their BOR, which is their best objective tumour response based on RECIST measurements throughout the whole study as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm.

Outcome measures

Outcome measures
Measure	Part A Schedule 2 480 mg bd n=6 Participants Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 400 mg bd n=7 Participants Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 560 mg bd n=12 Participants Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 640 mg bd n=8 Participants Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 360 mg bd n=5 Participants Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part B AZD5363 n=54 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Part B Placebo n=56 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
Best Objective Response (BOR) Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	4 Participants
Best Objective Response (BOR) Partial Response (PR)	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	29 Participants	28 Participants
Best Objective Response (BOR) Stable Disease (SD)	3 Participants	4 Participants	7 Participants	4 Participants	3 Participants	14 Participants	14 Participants
Best Objective Response (BOR) Progression	2 Participants	1 Participants	4 Participants	1 Participants	1 Participants	6 Participants	8 Participants
Best Objective Response (BOR) Not Evaluable (NE)	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).

Population: Part A:Full Analysis Set (FAS) Part B: Intent to Treat (ITT)

Percentage of patients, taking their best objective tumour response based on RECIST measurements throughout the whole study as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm. Overall Response Rate (ORR) = CR + PR

Outcome measures

Outcome measures
Measure	Part A Schedule 2 480 mg bd n=6 Participants Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 400 mg bd n=7 Participants Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 560 mg bd n=12 Participants Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 640 mg bd n=8 Participants Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 360 mg bd n=5 Participants Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part B AZD5363 n=54 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Part B Placebo n=56 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
Overall Objective Response Rate	0 % of participants	14.3 % of participants	0 % of participants	25 % of participants	20 % of participants	59.3 % of participants	57.1 % of participants

SECONDARY outcome

Timeframe: up to 12 weeks

Population: Part A Full Analysis Set (FAS). Not recorded in Part B.

Percentage of patients with a 12 week visit response of CR, PR or SD (as defined by RECIST 1.1) with no evidence of previous progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm.

Outcome measures

Outcome measures
Measure	Part A Schedule 2 480 mg bd n=6 Participants Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 400 mg bd n=7 Participants Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 560 mg bd n=12 Participants Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 640 mg bd n=8 Participants Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 360 mg bd n=5 Participants Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part B AZD5363 (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Part B Placebo (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
Number of Subjects Without Progression Disease at Week 12 - Part A	2 Participants	4 Participants	6 Participants	5 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).

Population: Part B, all patients with a response in the ITT analysis set. Not collected in Part A

Date of first documentation of response (Complete Response/Partial Response) until the date of disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm.. If a subject does not progress following a response, then their DOR will use the PFS censoring time.

Outcome measures

Outcome measures
Measure	Part A Schedule 2 480 mg bd Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 400 mg bd Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 560 mg bd Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 640 mg bd Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 360 mg bd Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part B AZD5363 n=54 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Part B Placebo n=56 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
Duration of Response (DOR) - Part B	—	—	—	—	—	8.3 Months Interval 6.0 to 11.3	8.2 Months Interval 5.6 to 10.6

SECONDARY outcome

Timeframe: From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).

Population: Part B, ITT analysis set. Not collected in Part A

Percentage of patients who have a Complete Response (CR) or Partial Response (PR) lasting continuously for at least 24 weeks as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: PR, \>=30% decrease in the sum of the longest diameter of target lesions; CR, disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10mm.

Outcome measures

Outcome measures
Measure	Part A Schedule 2 480 mg bd Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 400 mg bd Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 560 mg bd Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 640 mg bd Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 360 mg bd Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part B AZD5363 n=54 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Part B Placebo n=56 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
Durable Response Rate (DRR) - Part B	—	—	—	—	—	48.1 % of participants	37.5 % of participants

SECONDARY outcome

Timeframe: From date of randomisation, assessed every 12 weeks, up until the time of final statistical analysis. (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).

Population: Part B Intent to Treat (ITT). Not collected in Part A

The interval between the date of randomisation and the date of patient death due to any cause. All Part B patients were analysed, number of deaths is presented.

Outcome measures

Outcome measures
Measure	Part A Schedule 2 480 mg bd Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 400 mg bd Schedule 2 - AZD5363 400 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 560 mg bd Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 1 640 mg bd Schedule 1 - AZD5363 640 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 360 mg bd Schedule 2 - AZD5363 360 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part B AZD5363 n=54 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Part B Placebo n=56 Participants (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
Overall Survival - Part B	—	—	—	—	—	32.8 months Interval 21.3 to 32.8	NA months Interval 20.9 to NA = The median OS and the upper 95% Confidence limit were both non calculable

Adverse Events

Part A Schedule 1 560 mg bd

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Sched 1 - AZD5363 640 mg bd

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Sched 2 - AZD5363 360 mg bd

Serious events: 0 serious events

Other events: 5 other events

Deaths: 1 deaths

Sched 2 - AZD5363 400 mg bd

Serious events: 1 serious events

Other events: 7 other events

Deaths: 1 deaths

Part A Schedule 2 480 mg bd

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Part B AZD5363

Serious events: 13 serious events

Other events: 50 other events

Deaths: 13 deaths

Part B Placebo

Serious events: 8 serious events

Other events: 48 other events

Deaths: 15 deaths

Serious adverse events

Serious adverse events
Measure	Part A Schedule 1 560 mg bd n=12 participants at risk Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Sched 1 - AZD5363 640 mg bd n=8 participants at risk (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Sched 2 - AZD5363 360 mg bd n=5 participants at risk (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Sched 2 - AZD5363 400 mg bd n=7 participants at risk (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 480 mg bd n=6 participants at risk Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part B AZD5363 n=54 participants at risk (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Part B Placebo n=55 participants at risk (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
Blood and lymphatic system disorders Anaemia	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Blood and lymphatic system disorders Neutropenia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Diarrhoea	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Pyrexia	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Immune system disorders Drug hypersensitivity	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Lower respiratory tract infection bacterial	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Pneumonia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	7.4% 4/54 • Number of events 7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Urinary tract infection	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Renal and urinary disorders Renal failure	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Ascites	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Periodontal disease	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Asthenia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Catheter site cellulitis	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Cellulitis	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Device related infection	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Pyelonephritis	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Injury, poisoning and procedural complications Concussion	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Metabolism and nutrition disorders Dehydration	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Cerebrovascular accident	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Lethargy	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Urinary tract infection bacterial	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Urosepsis	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Injury, poisoning and procedural complications Upper limb fracture	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Renal and urinary disorders Acute kidney injury	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)

Other adverse events

Other adverse events
Measure	Part A Schedule 1 560 mg bd n=12 participants at risk Schedule 1 - AZD5363 560 mg bd (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Sched 1 - AZD5363 640 mg bd n=8 participants at risk (2 days on/5 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Sched 2 - AZD5363 360 mg bd n=5 participants at risk (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Sched 2 - AZD5363 400 mg bd n=7 participants at risk (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part A Schedule 2 480 mg bd n=6 participants at risk Schedule 2 - AZD5363 480 mg bd (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly. 3/4 weeks.	Part B AZD5363 n=54 participants at risk (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly	Part B Placebo n=55 participants at risk (4 days on/3 days off) with Paclitaxel 90 mg/m2 once weekly
Investigations Haemoglobin decreased	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Liver palpable	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Metabolism and nutrition disorders Calcium deficiency	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Metabolism and nutrition disorders Cell death	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Visual field defect	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Vascular disorders Lymphoedema	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Lower respiratory tract infection bacterial	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Blood and lymphatic system disorders Anaemia	50.0% 6/12 • Number of events 17 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	50.0% 4/8 • Number of events 16 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Blood and lymphatic system disorders Neutropenia	25.0% 3/12 • Number of events 20 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	37.5% 3/8 • Number of events 23 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Eye disorders Lacrimation increased	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Abdominal distension	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	5.5% 3/55 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Constipation	33.3% 4/12 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Diarrhoea	91.7% 11/12 • Number of events 66 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	87.5% 7/8 • Number of events 57 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Dry mouth	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Dyspepsia	8.3% 1/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Gastrointestinal sounds abnormal	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Mouth ulceration	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Nausea	66.7% 8/12 • Number of events 23 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	62.5% 5/8 • Number of events 6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Odynophagia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.6% 2/55 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Vomiting	33.3% 4/12 • Number of events 17 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Asthenia	50.0% 6/12 • Number of events 12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	62.5% 5/8 • Number of events 22 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Device breakage	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Fatigue	16.7% 2/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Malaise	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	7.4% 4/54 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	7.3% 4/55 • Number of events 8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Oedema peripheral	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Peripheral swelling	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Pyrexia	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	37.5% 3/8 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Gastroenteritis viral	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Hordeolum	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Nasopharyngitis	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Rhinitis	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Upper respiratory tract infection	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Urinary tract infection bacterial	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	5.6% 3/54 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Ejection fraction decreased	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Transaminases increased	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Metabolism and nutrition disorders Decreased appetite	33.3% 4/12 • Number of events 8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	37.5% 3/8 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Metabolism and nutrition disorders Hyperglycaemia	41.7% 5/12 • Number of events 39 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	37.5% 3/8 • Number of events 15 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Back pain	33.3% 4/12 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	37.5% 3/8 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Muscle spasms	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	25.0% 3/12 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Dysgeusia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.4% 11/54 • Number of events 13 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.7% 7/55 • Number of events 8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Headache	16.7% 2/12 • Number of events 7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	50.0% 4/8 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Lethargy	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	33.3% 2/6 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.6% 2/55 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Neuropathy peripheral	33.3% 4/12 • Number of events 13 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Neurotoxicity	41.7% 5/12 • Number of events 6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	37.5% 3/8 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Paraesthesia	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Peripheral sensory neuropathy	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Presyncope	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Psychiatric disorders Depressed mood	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Renal and urinary disorders Acute kidney injury	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Reproductive system and breast disorders Breast discharge	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Reproductive system and breast disorders Pelvic pain	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Respiratory, thoracic and mediastinal disorders Cough	41.7% 5/12 • Number of events 6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	37.5% 3/8 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Respiratory, thoracic and mediastinal disorders Dysphonia	16.7% 2/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	9.3% 5/54 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.6% 2/55 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	25.0% 3/12 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	37.5% 3/8 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Alopecia	25.0% 3/12 • Number of events 6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	50.0% 4/8 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Dry skin	25.0% 3/12 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Nail disorder	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Pruritus	16.7% 2/12 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Rash erythematous	16.7% 2/12 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	7.4% 4/54 • Number of events 8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Rash maculo-papular	8.3% 1/12 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Blood and lymphatic system disorders Leukopenia	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	37.5% 3/8 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.0% 1/5 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	33.3% 2/6 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Abdominal pain upper	25.0% 3/12 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	28.6% 2/7 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	5.5% 3/55 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Stomatitis	16.7% 2/12 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	28.6% 2/7 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	50.0% 3/6 • Number of events 10 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Toothache	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	7.4% 4/54 • Number of events 6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Influenza like illness	16.7% 2/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Immune system disorders Drug hypersensitivity	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	7.4% 4/54 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.6% 2/55 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Cellulitis	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Cystitis	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	5.6% 3/54 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Herpes zoster	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	5.5% 3/55 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Oral candidiasis	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	7.4% 4/54 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Oral herpes	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	5.6% 3/54 • Number of events 6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	5.5% 3/55 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Paronychia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	7.4% 4/54 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Urinary tract infection	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.8% 8/54 • Number of events 12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	9.1% 5/55 • Number of events 6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Vulvovaginal candidiasis	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	5.6% 3/54 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Alanine aminotransferase increased	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	24.1% 13/54 • Number of events 22 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	7.3% 4/55 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Aspartate aminotransferase increased	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 9 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	20.4% 11/54 • Number of events 19 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	7.3% 4/55 • Number of events 6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Blood alkaline phosphatase increased	8.3% 1/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Blood cholesterol increased	8.3% 1/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Blood creatinine increased	8.3% 1/12 • Number of events 6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Gamma-glutamyltransferase increased	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Lymphocyte count decreased	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	5.6% 3/54 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Neutrophil count decreased	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	7.4% 4/54 • Number of events 8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	5.5% 3/55 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Weight decreased	16.7% 2/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations White blood cell count decreased	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	7.3% 4/55 • Number of events 18 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	11.1% 6/54 • Number of events 8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	9.1% 5/55 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Metabolism and nutrition disorders Hypocalcaemia	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Metabolism and nutrition disorders Hypomagnesaemia	8.3% 1/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 2/12 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	33.3% 2/6 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Bone pain	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Myalgia	16.7% 2/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	42.9% 3/7 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Pain in extremity	8.3% 1/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Dizziness	25.0% 3/12 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	62.5% 5/8 • Number of events 7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	33.3% 2/6 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Neuralgia	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Psychiatric disorders Insomnia	8.3% 1/12 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Renal and urinary disorders Dysuria	8.3% 1/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Renal and urinary disorders Proteinuria	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	5.6% 3/54 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 2/12 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	28.6% 2/7 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Respiratory, thoracic and mediastinal disorders Epistaxis	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	28.6% 2/7 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	33.3% 2/6 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Erythema	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Nail discolouration	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	9.1% 5/55 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Onycholysis	16.7% 2/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	28.6% 2/7 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	7.4% 4/54 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	7.3% 4/55 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Rash	8.3% 1/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Rash papular	16.7% 2/12 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	5.6% 3/54 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Skin reaction	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	5.6% 3/54 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Vascular disorders Flushing	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	5.6% 3/54 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Vascular disorders Hypertension	16.7% 2/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Cardiac disorders Palpitations	8.3% 1/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Cardiac disorders Pericardial effusion	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Ear and labyrinth disorders Ear pain	8.3% 1/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Ear and labyrinth disorders Tinnitus	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	25.0% 2/8 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Ear and labyrinth disorders Vertigo	16.7% 2/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.6% 2/55 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Eye disorders Dry eye	16.7% 2/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Gastrointestinal pain	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Gingival bleeding	8.3% 1/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Haemorrhoids	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.6% 2/55 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Chest pain	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Non-cardiac chest pain	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.6% 2/55 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Suprapubic pain	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Fungal infection	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Influenza	16.7% 2/12 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.6% 2/55 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Pyelonephritis acute	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Sinusitis	8.3% 1/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Upper respiratory tract infection bacterial	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	33.3% 2/6 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Vaginal infection	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Varicella	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Viral upper respiratory tract infection	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Blood glucose increased	25.0% 3/12 • Number of events 5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Electrocardiogram QT prolonged	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.6% 2/55 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Thyroxine decreased	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Metabolism and nutrition disorders Hypercholesterolaemia	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Metabolism and nutrition disorders Hyponatraemia	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Neck pain	8.3% 1/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Migraine	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Radicular pain	8.3% 1/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Somnolence	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Psychiatric disorders Anxiety	8.3% 1/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	28.6% 2/7 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.6% 2/55 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Psychiatric disorders Sleep disorder	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Renal and urinary disorders Renal failure	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Reproductive system and breast disorders Vaginal discharge	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Respiratory, thoracic and mediastinal disorders Nasal dryness	16.7% 2/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	33.3% 2/6 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Respiratory, thoracic and mediastinal disorders Nasal obstruction	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Melanoderma	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Nail dystrophy	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Skin hyperpigmentation	8.3% 1/12 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Vascular disorders Hot flush	8.3% 1/12 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Cardiac disorders Left ventricular dysfunction	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Ear and labyrinth disorders Ear canal erythema	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Eye disorders Photopsia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Colitis	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Rectal tenesmus	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Catheter site related reaction	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Face oedema	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Hepatobiliary disorders Hepatomegaly	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Bacterial infection	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Conjunctivitis	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Folliculitis	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Viral infection	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Injury, poisoning and procedural complications Muscle strain	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Myoclonus	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Parosmia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Sciatica	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Tremor	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 4 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Psychiatric disorders Confusional state	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Psychiatric disorders Depression	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.7% 2/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Psychiatric disorders Hallucination	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Psychiatric disorders Irritability	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Renal and urinary disorders Haematuria	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	33.3% 2/6 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	3.6% 2/55 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Renal and urinary disorders Urinary incontinence	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Reproductive system and breast disorders Menorrhagia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	14.3% 1/7 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Eczema	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Skin and subcutaneous tissue disorders Generalised erythema	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Nervous system disorders Ageusia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/8 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	16.7% 1/6 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 3 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Ear and labyrinth disorders Hypoacusis	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Eye disorders Conjunctival pallor	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Eye disorders Visual acuity reduced	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Eye disorders Vitreous detachment	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Aphthous ulcer	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Dysphagia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Gastrointestinal disorders Flatulence	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
General disorders Hyperthermia	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Hepatobiliary disorders Hepatic pain	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Hepatobiliary disorders Hepatocellular injury	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Herpes virus infection	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Pharyngitis	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 2 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Infections and infestations Rash pustular	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Injury, poisoning and procedural complications Wound	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/54 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/55 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)
Investigations Blood bilirubin increased	0.00% 0/12 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	12.5% 1/8 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/5 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/7 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	0.00% 0/6 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.9% 1/54 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)	1.8% 1/55 • Number of events 1 • Time of signature of informed consent throughout the treatment period up to and including the follow-up period (median follow-up AZD5363 16.9 months; Placebo 15.2 months) The 5% threshold is applied to treatment schedule in Part A and then the Part A AEs are labelled as MedDRA v20.0 (schedule 1) or MedDRA v18.1 (schedule 2). The 5% threshold is applied to each Part B treatment arm and then the Part B AEs are labelled as MedDRA v19.1 One patient in the placebo group did not receive placebo treatment (hence n=56 for All Cause Mortality but n=55 for SAEs and Other AEs)

Additional Information

AstraZeneca Clinical

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place