Trial Outcomes & Findings for A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia (NCT NCT01358734)

NCT ID: NCT01358734

Last Updated: 2019-06-25

Results Overview

One-year survival rate was defined as all deaths within one year from the date of randomization. All others censored at the at year 1 or date of discontinuation

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 88 participants
• Primary outcome timeframe: Up to 24 months
• Results posted on: 2019-06-25

Participant Flow

Participants were randomized at 25 sites in North America (Canada and the United States).

Participants were centrally randomized 1:1:1 and stratified by the Eastern Cooperative Oncology Group (ECOG) performance score (0 to 1 versus 2) and peripheral blood blast count (<1 versus ≥ 1 x 10^9/L).

Participant milestones

Measure	Lenalidomide Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.	Azacitidine Plus Lenalidomide Participants received azacitidine 75 mg/m\^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC	Azacitidine Participants received azacitidine 75mg/m\^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Study STARTED	15	39	34
Overall Study Safety Population	14	38	32
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	15	39	34

Reasons for withdrawal

Measure	Lenalidomide Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.	Azacitidine Plus Lenalidomide Participants received azacitidine 75 mg/m\^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC	Azacitidine Participants received azacitidine 75mg/m\^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Study Adverse Event	4	7	3
Overall Study Lack of Efficacy	0	1	3
Overall Study Withdrawal by Subject	1	6	3
Overall Study Death	3	7	2
Overall Study Progressive Disease	5	13	16
Overall Study Non-compliance with study drug	0	0	1
Overall Study Other	2	5	4
Overall Study Protocol Violation	0	0	2

Baseline Characteristics

A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia

Baseline characteristics by cohort

Measure	Lenalidomide n=15 Participants Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.	Azacitidine + Lenalidomide n=39 Participants Participants received azacitidine 75 mg/m\^2/ daily SC on Days 1 through 7 and lenalidomide 50 mg daily PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care	Azacitidine n=34 Participants Participants received azacitidine 75mg/m\^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC	Total n=88 Participants Total of all reporting groups
Age, Continuous	77.6 years STANDARD_DEVIATION 5.47 • n=5 Participants	75.5 years STANDARD_DEVIATION 5.88 • n=7 Participants	74.8 years STANDARD_DEVIATION 4.96 • n=5 Participants	75.97 years STANDARD_DEVIATION 5.44 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	17 Participants n=7 Participants	15 Participants n=5 Participants	35 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	22 Participants n=7 Participants	19 Participants n=5 Participants	53 Participants n=4 Participants
Eastern Cooperative Oncology Group Performance Status 0 = (Fully Active)	4 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants	18 Participants n=4 Participants
Eastern Cooperative Oncology Group Performance Status 1 = (Restrictive but ambulatory)	9 Participants n=5 Participants	28 Participants n=7 Participants	17 Participants n=5 Participants	54 Participants n=4 Participants
Eastern Cooperative Oncology Group Performance Status (Ambulatory but unable to work)	2 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants
Eastern Cooperative Oncology Group Performance Status 3 = (Limited self care)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Eastern Cooperative Oncology Group Performance Status 4 = (Completely Disabled)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Eastern Cooperative Oncology Group Performance Status Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Peripheral Blast Blood Count <1 X 10^9L	11 Participants n=5 Participants	31 Participants n=7 Participants	27 Participants n=5 Participants	69 Participants n=4 Participants
Peripheral Blast Blood Count ≥1 X 10^9L	4 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Population: ITT included all randomized participants

One-year survival rate was defined as all deaths within one year from the date of randomization. All others censored at the at year 1 or date of discontinuation

Outcome measures

Measure	Lenalidomide n=15 Participants Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.	Azacitidine Plus Lenalidomide n=39 Participants Participants received azacitidine 75 mg/m\^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC	Azacitidine n=34 Participants Participants received azacitidine 75mg/m\^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Kaplan Meier Estimates for One Year Survival	3.00 months Interval 1.18 to 11.93	9.61 months Interval 3.18 to 19.31	13.67 months Interval 6.75 to The Upper limit of the 95% Confidence Interval could not be estimated due to an insufficient number of participants with events.

PRIMARY outcome

Timeframe: From date of randomization until the date of the first documented date of progression or date of death of any cause; the overall median follow-up for survivng participants was 4.1 months (range 0.2 to 54.8 months)

Population: Participants who were still alive at the end of the study and in safety population.

Overall Survival reported at the end of the study are for those participants who were alive at the end of the study

Outcome measures

Measure	Lenalidomide n=1 Participants Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.	Azacitidine Plus Lenalidomide n=4 Participants Participants received azacitidine 75 mg/m\^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC	Azacitidine n=3 Participants Participants received azacitidine 75mg/m\^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Overall Survival	0.2 months Interval 0.2 to 0.2	7.1 months Interval 1.4 to 53.3	4.1 months Interval 0.2 to 54.8

SECONDARY outcome

Timeframe: Complete Response or Morphologic Incomplete Response data not analyzed.

Population: Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Based on IWG response criteria for AML. Complete remission (CR), morphologic complete remission (CR) was defined as < 5% bone marrow blasts, an absolute neutrophil count ≥ 1 x 10^9/L, platelets ≥100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response.

Morphologic CR with incomplete blood count recovery (CRi) was defined as a morphologic complete remission but the ANC count may be <1 x 10^9/L and/or the platelet count may be <100 x 10^9/L. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of Remission (DoR) time frame not analyzed.

Population: Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Duration of remission was defined as the time from the date of CR or CRi until relapse. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cytogenetic Complete Remission timeframe was not analyzed.

Population: Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

The CRc response category is comprised of the subset of participants who had abnormal cytogenetics at baseline and subsequently achieved CR during treatment in conjunction with a reversion to a normal karyotype. For the primary definition of CRc, a normal karyotype is defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) 1) CR criteria met AND 2) Abnormal karyotype present at baseline AND 3) Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Overall response rate time frame was not analyzed.

Population: Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Morphologic complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a one marrow aspirate with spicules and with at least 200 nucleated cells (there should be no blasts with auer rods) and ANC of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, no transfusions for 1 week prior to each assessment. No duration of these findings is required for confirmation of this response. Morphologic complete remission with incomplete blood count recovery was defined as a morphologic complete remission but the ANC may be < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Partial remission was defined as an ANC > 1 x 10^9/L and platelet count ≥ 100 x 10^9/L with a > 50% decrease in the percentage of bone marrow blasts to 5% to 25% (a blast count value of ≤ 5% may also be considered a partial remission if auer rods are present). Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Progression-Free survival data and time frame was not analyzed.

Population: Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

PFS is defined as the time from randomization to the first observation of documented disease progression or death from any cause whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Event-Free survival time was not analyzed.

Population: Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

EFS was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after CR or CRi, or death from any cause, whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Relapse-Free survival time frame was not analyzed.

Population: Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

RFS is defined only for subjects that achieve CR and CRi and is measured as the interval from that date to the date of disease relapse, death from any cause, whichever occurs first, censoring at the last visit date for subjects alive in continuous CR/CRi. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Population: ITT included all randomized participants.

30-day mortality rate was defined as death from any cause within 30 days after first dose.

Outcome measures

Measure	Lenalidomide n=15 Participants Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.	Azacitidine Plus Lenalidomide n=39 Participants Participants received azacitidine 75 mg/m\^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC	Azacitidine n=34 Participants Participants received azacitidine 75mg/m\^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Percentage of Participants With 30-Day Treatment-Related Mortality	13.3 percentage of participants	17.9 percentage of participants	5.9 percentage of participants

SECONDARY outcome

Timeframe: From the first dose of study drug up to 28 days after the last dose of study drug; up to 15 May 2018

Population: Safety population includes all participants who have received at least 1 dose of Investigational Product.

TEAEs were defined as those events that started on or after the first day of study drug up until 28 days after the last dose of study drug; Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; constitutes an important medical event. Severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); and according to the scale: Grade (Gr) 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death

Outcome measures

Measure	Lenalidomide n=14 Participants Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.	Azacitidine Plus Lenalidomide n=38 Participants Participants received azacitidine 75 mg/m\^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC	Azacitidine n=32 Participants Participants received azacitidine 75mg/m\^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Number of Participants With Treatment Emergent Adverse Events (TEAE) ≥1 TEAE CTCAE Gr 3 or 4 TEAE related to study drug	11 participants	25 participants	18 participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) Any TEAE	14 participants	38 participants	32 participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) ≥1 TEAE related to study drug	13 participants	35 participants	30 participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) ≥1 TEAE CTCAE Grade 3 or 4 TEAE	14 participants	34 participants	29 participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) ≥1 TEAE CTCAE Grade 5	5 participants	10 participants	5 participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) ≥1 Serious TEAE	13 participants	29 participants	25 participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) ≥1 Serious TEAE related to study drug	10 participants	16 participants	7 participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) ≥1TEAE leading to discontinuation of study drug	6 participants	12 participants	4 participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) ≥1TEAE leading to dose reduction of study drug	0 participants	8 participants	2 participants
Number of Participants With Treatment Emergent Adverse Events (TEAE) ≥1TEAE leading to dose interruption of study drug	8 participants	21 participants	10 participants

SECONDARY outcome

Timeframe: From randomization of the last participant up to a minimum of 4 years following discontinuation

Population: Safety population includes all participants who received at least one dose of IP

Second primary malignancies were monitored as events of interest and reported as serious adverse events regardless of the treatment arm the participant was enrolled in.

Outcome measures

Measure	Lenalidomide n=14 Participants Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.	Azacitidine Plus Lenalidomide n=38 Participants Participants received azacitidine 75 mg/m\^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC	Azacitidine n=32 Participants Participants received azacitidine 75mg/m\^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Number of Participants With a Second Primary Malignancy	0 Participants	0 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 12 months

Population: ITT population included participants who were randomized.

Defined as the percentage of participants who survived at one year

Outcome measures

Measure	Lenalidomide n=15 Participants Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.	Azacitidine Plus Lenalidomide n=39 Participants Participants received azacitidine 75 mg/m\^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC	Azacitidine n=34 Participants Participants received azacitidine 75mg/m\^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Percentage of Participants Alive at One Year	21.4 Percentage of participants Interval 0.0 to 42.9	43.9 Percentage of participants Interval 27.9 to 59.9	52.3 Percentage of participants Interval 34.7 to 69.8

Adverse Events

Lenalidomide

Serious events: 13 serious events

Other events: 14 other events

Deaths: 7 deaths

Azacitidine Plus Lenalidomide

Serious events: 29 serious events

Other events: 38 other events

Deaths: 34 deaths

Azacitidine

Serious events: 25 serious events

Other events: 32 other events

Deaths: 29 deaths

Serious adverse events

Measure	Lenalidomide n=14 participants at risk Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.	Azacitidine Plus Lenalidomide n=38 participants at risk Participants received azacitidine 75 mg/m\^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC	Azacitidine n=32 participants at risk Participants received azacitidine 75mg/m\^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Blood and lymphatic system disorders Febrile neutropenia	42.9% 6/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	42.1% 16/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	25.0% 8/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Anaemia	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Thrombocytopenia	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Disseminated intravascular coagulation	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Leukocytosis	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Neutropenia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Pneumonia	21.4% 3/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	21.9% 7/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Sepsis	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Cellulitis	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Septic shock	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Bronchopulmonary aspergillosis	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Clostridium difficile colitis	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Klebsiella bacteraemia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Subcutaneous abscess	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Breast abscess	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Clostridium difficile infection	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Enterobacter bacteraemia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Herpes zoster	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Klebsiella sepsis	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Lobar pneumonia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Lung infection	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Osteomyelitis	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Pneumonia fungal	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Pneumonia staphylococcal	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Postoperative wound infection	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Pseudomonas infection	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Scrotal abscess	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Soft tissue infection	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Urinary tract infection	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Urinary tract infection enterococcal	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Fatigue	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Non-cardiac chest pain	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Pyrexia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Asthenia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Malaise	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Oedema peripheral	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Performance status decreased	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Systemic inflammatory response syndrome	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Atrial fibrillation	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Angina pectoris	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Angina unstable	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Atrial flutter	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Cardiac arrest	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Cardiac failure	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Cardiac failure congestive	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Cardio-respiratory arrest	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Dehydration	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Decreased appetite	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Fluid overload	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Tumour lysis syndrome	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Failure to thrive	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Syncope	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Central nervous system lesion	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Cerebrovascular accident	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Depressed level of consciousness	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Haemorrhage intracranial	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Status epilepticus	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Transient ischaemic attack	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Constipation	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Diarrhoea	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Arthritis	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Fall	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Head injury	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Blast cell count increased	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Blood bilirubin increased	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Bone marrow myelogram abnormal	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Megakaryocytes decreased	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Renal and urinary disorders Renal failure acute	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Renal and urinary disorders Renal failure	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Renal and urinary disorders Urinary retention	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Vascular disorders Deep vein thrombosis	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Vascular disorders Hypotension	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Vascular disorders Orthostatic hypotension	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemic infiltration extramedullary	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer stage 0	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Angioedema	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.

Other adverse events

Measure	Lenalidomide n=14 participants at risk Participants received lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus BSC, including antibiotics and transfusions, at the investigator's discretion.	Azacitidine Plus Lenalidomide n=38 participants at risk Participants received azacitidine 75 mg/m\^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on days 8 through 28 followed by a 14-day rest period plus BSC	Azacitidine n=32 participants at risk Participants received azacitidine 75mg/m\^2 administered SC on days 1 through 7 followed by a 21-day rest period plus BSC
Cardiac disorders Angina pectoris	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Constipation	50.0% 7/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	63.2% 24/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	53.1% 17/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Nausea	28.6% 4/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	50.0% 19/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	68.8% 22/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Diarrhoea	35.7% 5/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	50.0% 19/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	25.0% 8/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Vomiting	21.4% 3/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.4% 7/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	37.5% 12/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Abdominal pain	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	13.2% 5/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.8% 6/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Oral disorder	21.4% 3/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Stomatitis	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	9.4% 3/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Dysphagia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	13.2% 5/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Haemorrhoids	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	9.4% 3/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Dry mouth	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Dyspepsia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Gastrooesophageal reflux disease	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Oral pain	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Abdominal distension	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Mouth haemorrhage	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Tongue ulceration	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Toothache	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Faeces discoloured	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Flatulence	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Gingival bleeding	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Abdominal tenderness	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Gastrointestinal haemorrhage	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Odynophagia	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Gastrointestinal disorders Tongue coated	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Fatigue	57.1% 8/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	39.5% 15/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	43.8% 14/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Oedema peripheral	42.9% 6/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.4% 7/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	21.9% 7/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Pyrexia	21.4% 3/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	23.7% 9/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	25.0% 8/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Asthenia	28.6% 4/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.4% 7/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	9.4% 3/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Chills	21.4% 3/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	13.2% 5/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Injection site erythema	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.8% 6/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Injection site reaction	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.8% 6/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Injection site pain	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.4% 7/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Pain	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	9.4% 3/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Mucosal inflammation	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Device occlusion	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Injection site bruising	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	9.4% 3/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Injection site irritation	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Non-cardiac chest pain	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Catheter site pain	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Face oedema	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Facial pain	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Gait disturbance	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Generalised oedema	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Injection site discomfort	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Localised oedema	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Malaise	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Mucosal haemorrhage	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Oedema	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Feeling abnormal	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
General disorders Local swelling	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Cough	35.7% 5/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	31.6% 12/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	25.0% 8/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	21.4% 3/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	42.1% 16/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	12.5% 4/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Epistaxis	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	15.8% 6/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.8% 6/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.4% 7/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	15.6% 5/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	9.4% 3/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	9.4% 3/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Tachypnoea	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Lung infiltration	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Rales	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Lung disorder	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Respiratory, thoracic and mediastinal disorders Respiratory distress	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Weight decreased	35.7% 5/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	39.5% 15/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	31.2% 10/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Neutrophil count decreased	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	13.2% 5/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	12.5% 4/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations White blood cell count decreased	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	15.6% 5/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Platelet count decreased	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	15.8% 6/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Alanine aminotransferase increased	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	13.2% 5/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Aspartate aminotransferase increased	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	13.2% 5/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Blood magnesium decreased	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Blood creatinine increased	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Cardiac murmur	21.4% 3/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations International normalised ratio increased	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Lymphocyte count decreased	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Blood bilirubin increased	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Transaminases increased	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Weight increased	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Blood alkaline phosphatase increased	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Oxygen saturation decreased	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Staphylococcus test positive	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Vitamin D decreased	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Activated partial thromboplastin time abnormal	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Clostridium test positive	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Investigations Electrocardiogram QT prolonged	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Bradycardia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Pneumonia	21.4% 3/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	12.5% 4/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Cellulitis	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	13.2% 5/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	12.5% 4/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Urinary tract infection	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.8% 6/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Upper respiratory tract infection	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	15.8% 6/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	9.4% 3/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Herpes simplex	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Oral candidiasis	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	9.4% 3/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Herpes zoster	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	9.4% 3/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Nasopharyngitis	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Respiratory tract infection	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Sinusitis	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Fungal infection	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Furuncle	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Hordeolum	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Oral herpes	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Rash pustular	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Tooth abscess	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Clostridium difficile colitis	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Ear infection	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Mucosal infection	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Osteomyelitis	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Tooth infection	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Infections and infestations Body tinea	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Decreased appetite	28.6% 4/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	47.4% 18/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	31.2% 10/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Hypokalaemia	50.0% 7/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	31.6% 12/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	25.0% 8/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	21.1% 8/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Hyponatraemia	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	13.2% 5/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Hypocalcaemia	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	12.5% 4/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Sinus tachycardia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Hypoalbuminaemia	28.6% 4/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Dehydration	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	12.5% 4/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	13.2% 5/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Hyperglycaemia	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Fluid overload	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Failure to thrive	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Glucose tolerance impaired	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Hyperphosphataemia	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Hyperuricaemia	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Metabolism and nutrition disorders Vitamin K deficiency	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Anaemia	42.9% 6/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	28.9% 11/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	31.2% 10/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Thrombocytopenia	21.4% 3/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	28.9% 11/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	34.4% 11/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Neutropenia	28.6% 4/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	15.8% 6/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	28.1% 9/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	15.8% 6/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Pancytopenia	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Leukocytosis	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Leukopenia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Spleen disorder	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Blood and lymphatic system disorders Splenic lesion	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Pruritus	21.4% 3/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	36.8% 14/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Rash	21.4% 3/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	26.3% 10/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.8% 6/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.4% 7/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Petechiae	21.4% 3/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Rash generalised	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Decubitus ulcer	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Hyperhidrosis	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Rash erythematous	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Blister	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Rash macular	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Skin exfoliation	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Skin ulcer	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Urticaria	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Skin and subcutaneous tissue disorders Dermal cyst	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Arthralgia	21.4% 3/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	21.1% 8/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	34.4% 11/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Back pain	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	28.1% 9/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Pain in extremity	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.4% 7/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	9.4% 3/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Muscular weakness	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.4% 7/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Muscle spasms	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	12.5% 4/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Arthritis	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	9.4% 3/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Joint swelling	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Arthropathy	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Bursitis	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Musculoskeletal and connective tissue disorders Osteoarthritis	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Atrial flutter	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Dizziness	21.4% 3/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	31.6% 12/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.8% 6/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Headache	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	23.7% 9/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	12.5% 4/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Dysgeusia	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	15.8% 6/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	9.4% 3/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Syncope	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	9.4% 3/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Tremor	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Neuropathy peripheral	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Balance disorder	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Hypoaesthesia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Paraesthesia	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Nervous system disorders Presyncope	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Psychiatric disorders Insomnia	28.6% 4/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	21.1% 8/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Psychiatric disorders Anxiety	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	26.3% 10/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	9.4% 3/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Psychiatric disorders Depression	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	12.5% 4/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Psychiatric disorders Confusional state	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	10.5% 4/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Psychiatric disorders Agitation	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Psychiatric disorders Mental status changes	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Psychiatric disorders Delirium	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Atrial fibrillation	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	13.2% 5/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Tachycardia	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	15.6% 5/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Cardiac failure congestive	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Cardiac disorder	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Cardiac disorders Supraventricular tachycardia	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Vascular disorders Hypotension	28.6% 4/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	15.8% 6/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Vascular disorders Hypertension	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Vascular disorders Deep vein thrombosis	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Vascular disorders Orthostatic hypotension	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Vascular disorders Thrombophlebitis superficial	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Vascular disorders Venous thrombosis limb	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Vascular disorders Phlebitis	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Contusion	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	13.2% 5/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	18.8% 6/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Fall	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Procedural pain	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Scratch	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Transfusion reaction	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Wound	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Cartilage injury	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Ligament sprain	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Muscle injury	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Muscle rupture	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Injury, poisoning and procedural complications Upper limb fracture	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Renal and urinary disorders Dysuria	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	7.9% 3/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	12.5% 4/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Renal and urinary disorders Haematuria	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	13.2% 5/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Renal and urinary disorders Renal failure acute	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Renal and urinary disorders Urinary retention	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Renal and urinary disorders Pollakiuria	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Renal and urinary disorders Renal cyst	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Renal and urinary disorders Renal failure	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	2.6% 1/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Renal and urinary disorders Azotaemia	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Renal and urinary disorders Renal disorder	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Renal and urinary disorders Renal tubular necrosis	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Ear and labyrinth disorders Ear congestion	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Ear and labyrinth disorders Ear discomfort	0.00% 0/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	6.2% 2/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Ear and labyrinth disorders Hypoacusis	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Eye disorders Vision blurred	14.3% 2/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	3.1% 1/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Eye disorders Erythema of eyelid	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Eye disorders Eye inflammation	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Eye disorders Lacrimation increased	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Hepatobiliary disorders Hyperbilirubinaemia	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	5.3% 2/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	7.1% 1/14 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/38 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.	0.00% 0/32 • From the date of randomization to 28 days after the last dose of study drug. Up to 15 May 2018. Between the date of first dose of IP up until and 28 days after the date of last dose of IP or that were present prior to the first day of IP but increased in severity or were assessed as related to IP during the study, including the follow-up 28-day time interval. All-cause mortality includes all deaths that occurred during the entire study.

Additional Information

Anne McClain, Senior Manager, Clinical Trial Disclosure

Celgene Corporation

Phone: 888-260-1599

Email: ClinicalTrialDisclosure@celgene.com

Results disclosure agreements

• Principal investigator is a sponsor employee Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications
• Publication restrictions are in place

Restriction type: OTHER