Trial Outcomes & Findings for On Open-Label Study in Participants With Systemic Lupus Erythematosus (NCT NCT01488708)

NCT ID: NCT01488708

Last Updated: 2018-05-17

Results Overview

A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1518 participants
• Primary outcome timeframe: Baseline through 4 years
• Results posted on: 2018-05-17

Participant Flow

Participant milestones

Measure	LY 2127399 Q2W If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.	LY2127399 Q4W If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.
Overall Study STARTED	940	578
Overall Study Received at Least 1 Dose of Study Drug	937	578
Overall Study Participated in Follow Up	810	526
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	940	578

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

On Open-Label Study in Participants With Systemic Lupus Erythematosus

Baseline characteristics by cohort

Measure	LY 2127399 Q2W n=940 Participants If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.	LY2127399 Q4W n=578 Participants If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.	Total n=1518 Participants Total of all reporting groups
Age, Continuous	43.6 years STANDARD_DEVIATION 12.12 • n=5 Participants	40.4 years STANDARD_DEVIATION 11.35 • n=7 Participants	42.4 years STANDARD_DEVIATION 11.93 • n=5 Participants
Sex: Female, Male Female	880 Participants n=5 Participants	527 Participants n=7 Participants	1407 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	51 Participants n=7 Participants	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	265 Participants n=5 Participants	189 Participants n=7 Participants	454 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	612 Participants n=5 Participants	314 Participants n=7 Participants	926 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	63 Participants n=5 Participants	75 Participants n=7 Participants	138 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	104 Participants n=5 Participants	94 Participants n=7 Participants	198 Participants n=5 Participants
Race (NIH/OMB) Asian	113 Participants n=5 Participants	96 Participants n=7 Participants	209 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	130 Participants n=5 Participants	33 Participants n=7 Participants	163 Participants n=5 Participants
Race (NIH/OMB) White	579 Participants n=5 Participants	337 Participants n=7 Participants	916 Participants n=5 Participants
Race (NIH/OMB) More than one race	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	449 Participants n=5 Participants	83 Participants n=7 Participants	532 Participants n=5 Participants
Region of Enrollment Puerto Rico	14 Participants n=5 Participants	1 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment Canada	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment Peru	31 Participants n=5 Participants	38 Participants n=7 Participants	69 Participants n=5 Participants
Region of Enrollment Brazil	18 Participants n=5 Participants	36 Participants n=7 Participants	54 Participants n=5 Participants
Region of Enrollment Mexico	23 Participants n=5 Participants	28 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment Ecuador	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Region of Enrollment Argentina	16 Participants n=5 Participants	23 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment Colombia	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment Guatemala	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment Chile	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Philippines	33 Participants n=5 Participants	26 Participants n=7 Participants	59 Participants n=5 Participants
Region of Enrollment Taiwan	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment Japan	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment South Korea	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment Thailand	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment Australia	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment New Zealand	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Malaysia	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Singapore	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Serbia	27 Participants n=5 Participants	36 Participants n=7 Participants	63 Participants n=5 Participants
Region of Enrollment Hungary	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Region of Enrollment Poland	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Region of Enrollment Russia	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment Ukraine	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment Romania	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment Spain	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment Germany	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment Belarus	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Bulgaria	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Latvia	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Macedonia	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Austria	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Italy	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Croatia	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment France	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Tunisia	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment South Africa	13 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment Israel	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment Egypt	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United Kingdom	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) Score	5.4 units on a scale STANDARD_DEVIATION 3.81 • n=5 Participants	4.9 units on a scale STANDARD_DEVIATION 3.74 • n=7 Participants	5.2 units on a scale STANDARD_DEVIATION 3.79 • n=5 Participants
Anti-dsDNA Antibody Level (IU)	82.9 International Unit/Milliliter (IU/mL) STANDARD_DEVIATION 102.03 • n=5 Participants	92.3 International Unit/Milliliter (IU/mL) STANDARD_DEVIATION 102.35 • n=7 Participants	86.4 International Unit/Milliliter (IU/mL) STANDARD_DEVIATION 102.23 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline through 4 years

Population: All participants who received at least 1 dose of study drug.

A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Outcome measures

Measure	LY 2127399 Q2W n=937 Participants If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.	LY2127399 Q4W n=578 Participants If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.
Percentage of Participants With Adverse Events (AEs)	73.3 percentage of participants	65.6 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Zero participants analyzed. Data was not collected for analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 4 years

Population: Zero participants analyzed. Data was not collected for analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 4 years

Population: Zero participants analyzed. Data was not collected for analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline through 4 years

Population: Zero participants analyzed. Data was not collected for analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

Population: Zero participants analyzed. Data was not collected for analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 4 years

Population: Zero participants analyzed. Data was not collected for analysis.

Outcome measures

Outcome data not reported

Adverse Events

LY 2127399 Q2W Treatment

Serious events: 129 serious events

Other events: 464 other events

Deaths: 0 deaths

LY2127399 Q4W Treatment

Serious events: 64 serious events

Other events: 232 other events

Deaths: 0 deaths

LY 2127399 Q2W Follow Up

Serious events: 57 serious events

Other events: 37 other events

Deaths: 0 deaths

LY2127399 Q4W Follow Up

Serious events: 51 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Measure	LY 2127399 Q2W Treatment n=937 participants at risk If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.	LY2127399 Q4W Treatment n=578 participants at risk If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.	LY 2127399 Q2W Follow Up n=810 participants at risk If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. Follow up.	LY2127399 Q4W Follow Up n=526 participants at risk If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. Follow up.
Infections and infestations Staphylococcal skin infection	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Subcutaneous abscess	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Staphylococcal sepsis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Haemolytic uraemic syndrome	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Histiocytosis haematophagic	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Iron deficiency anaemia	0.32% 3/937 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Leukopenia	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Neutropenia	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.35% 2/578 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Acute myocardial infarction	0.32% 3/937 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Angina pectoris	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Atrioventricular block	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Atrioventricular block complete	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Atrioventricular block second degree	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Bundle branch block bilateral	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Cardiac arrest	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Cardiac failure congestive	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Coronary artery disease	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Myocardial fibrosis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Myocardial infarction	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Pericardial effusion	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Pericarditis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Right ventricular failure	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Tachycardia	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.35% 2/578 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Cardiac disorders Tricuspid valve disease	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Endocrine disorders Adrenal insufficiency	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Endocrine disorders Adrenocortical insufficiency acute	0.11% 1/937 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Endocrine disorders Mineralocorticoid deficiency	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Eye disorders Amaurosis fugax	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Eye disorders Cataract	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Eye disorders Diplopia	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Eye disorders Eyelid ptosis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	0.43% 4/937 • Number of events 4 All randomized participants who received at least 1 dose of study drug.	0.35% 2/578 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Colitis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Colitis ulcerative	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.25% 2/810 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastritis	0.32% 3/937 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastritis erosive	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Hiatus hernia	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Intestinal ischaemia	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Intestinal perforation	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Large intestine polyp	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Oesophagitis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Pancreatitis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
General disorders Death	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
General disorders Device dislocation	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
General disorders Implant site erosion	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
General disorders Medical device complication	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
General disorders Non-cardiac chest pain	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.37% 3/810 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
General disorders Pelvic mass	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.25% 2/810 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Hepatobiliary disorders Cholecystitis	0.32% 3/937 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Hepatobiliary disorders Cholecystitis acute	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Hepatobiliary disorders Cholelithiasis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Hepatobiliary disorders Liver disorder	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Hepatobiliary disorders Nodular regenerative hyperplasia	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Immune system disorders Drug hypersensitivity	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Abdominal abscess	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Abscess	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Amoebiasis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Appendicitis	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.35% 2/578 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Arthritis bacterial	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Bacteraemia	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Blastocystis infection	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Brain abscess	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Bronchitis	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Bronchitis bacterial	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Cellulitis	0.32% 3/937 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.37% 3/810 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Cervicitis	0.00% 0/877 All randomized participants who received at least 1 dose of study drug.	0.19% 1/527 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Cytomegalovirus infection	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Diverticulitis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Enterocolitis bacterial	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Escherichia urinary tract infection	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Gastroenteritis	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Groin abscess	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Herpes zoster	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.38% 2/526 • Number of events 2 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Herpes zoster disseminated	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Infectious colitis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Influenza	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Kidney infection	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Lobar pneumonia	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Localised infection	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Meningitis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Meningitis cryptococcal	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Meningitis viral	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Oesophageal candidiasis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Oral fungal infection	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Peritonitis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Peritonsillar abscess	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Pharyngotonsillitis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Pneumococcal sepsis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	1.2% 11/937 • Number of events 12 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia bacterial	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Post procedural infection	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Pulmonary tuberculosis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Pyelonephritis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Pyonephrosis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Respiratory tract infection	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Sepsis	0.32% 3/937 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Sepsis syndrome	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Septic shock	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Sinusitis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Tooth abscess	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	0.32% 3/937 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	0.32% 3/937 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.52% 3/578 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.25% 2/810 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.57% 3/526 • Number of events 3 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Varicella	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Viral infection	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Vulval cellulitis	0.11% 1/877 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/527 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Ankle fracture	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Bone fissure	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Bronchial injury	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Concussion	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Contusion	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Femoral neck fracture	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Gun shot wound	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Head injury	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Joint injury	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Ligament rupture	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Ligament sprain	0.11% 1/937 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Muscle strain	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Overdose	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Procedural intestinal perforation	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Respiratory fume inhalation disorder	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Road traffic accident	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Spinal compression fracture	0.32% 3/937 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Investigations Electrocardiogram QRS complex shortened	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Investigations Lipase increased	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Cholesterosis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Dehydration	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.11% 1/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.35% 2/578 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Ketosis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthritis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.85% 8/937 • Number of events 9 All randomized participants who received at least 1 dose of study drug.	0.35% 2/578 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.25% 2/810 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders SLE arthritis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.43% 4/937 • Number of events 4 All randomized participants who received at least 1 dose of study drug.	0.52% 3/578 • Number of events 4 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.95% 5/526 • Number of events 5 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Tendon disorder	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign vaginal neoplasm	0.11% 1/877 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/527 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brenner tumour	0.11% 1/877 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/527 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/50 All randomized participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/760 All randomized participants who received at least 1 dose of study drug.	0.21% 1/482 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.11% 1/877 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/527 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.11% 1/877 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/527 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Carotid artery dissection	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Cerebrovascular disorder	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Epilepsy	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Headache	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Hemiparesis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders IIIrd nerve disorder	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Migraine	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Neuropathy peripheral	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Neuropsychiatric lupus	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Optic neuritis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Subarachnoid haemorrhage	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Syncope	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.35% 2/578 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Tension headache	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Transient ischaemic attack	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders VIIth nerve paralysis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders VIth nerve disorder	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Pregnancy, puerperium and perinatal conditions Abortion	0.11% 1/877 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/527 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.11% 1/877 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.19% 1/527 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Pregnancy, puerperium and perinatal conditions Blighted ovum	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/760 All randomized participants who received at least 1 dose of study drug.	0.21% 1/482 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.11% 1/877 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/527 All randomized participants who received at least 1 dose of study drug.	0.13% 1/760 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/482 All randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Anxiety	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Conversion disorder	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Delirium tremens	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Depression	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Generalised anxiety disorder	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Mental status changes	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Suicide attempt	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Bladder prolapse	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Calculus ureteric	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Glomerulonephritis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Hydronephrosis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Lupus nephritis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.25% 2/810 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.76% 4/526 • Number of events 4 All randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Renal failure acute	0.21% 2/937 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.35% 2/578 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary retention	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/60 All randomized participants who received at least 1 dose of study drug.	2.0% 1/51 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/50 All randomized participants who received at least 1 dose of study drug.	2.3% 1/44 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/877 All randomized participants who received at least 1 dose of study drug.	0.19% 1/527 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/760 All randomized participants who received at least 1 dose of study drug.	0.21% 1/482 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Metrorrhagia	0.11% 1/877 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/527 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/877 All randomized participants who received at least 1 dose of study drug.	0.19% 1/527 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.25% 2/810 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.43% 4/937 • Number of events 4 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.37% 3/810 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.35% 2/578 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural fibrosis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.25% 2/810 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Upper airway obstruction	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dry gangrene	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Mucocutaneous ulceration	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Precancerous skin lesion	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Psoriasis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin ulcer	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Vascular disorders Deep vein thrombosis	0.21% 2/937 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Vascular disorders Extremity necrosis	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	0.43% 4/937 • Number of events 4 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.49% 4/810 • Number of events 4 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Vascular disorders Hypotension	0.11% 1/937 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Vascular disorders Infarction	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Vascular disorders Orthostatic hypotension	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 2 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.12% 1/810 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Vascular disorders Poor venous access	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Vascular disorders Shock haemorrhagic	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Vascular disorders Thrombophlebitis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Vascular disorders Vasculitis	0.11% 1/937 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/578 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Vascular disorders Venous occlusion	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.
Vascular disorders Venous thrombosis limb	0.00% 0/937 All randomized participants who received at least 1 dose of study drug.	0.17% 1/578 • Number of events 1 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.19% 1/526 • Number of events 1 All randomized participants who received at least 1 dose of study drug.

Other adverse events

Measure	LY 2127399 Q2W Treatment n=937 participants at risk If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.	LY2127399 Q4W Treatment n=578 participants at risk If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. LY2127399: 120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug. Placebo: Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.	LY 2127399 Q2W Follow Up n=810 participants at risk If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at week 0, followed by 1 SC injection of 120 mg LY2127399 every 2 weeks (Q2W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at Week 0, followed by 1 SC injection of 120 mg LY2127399 Q2W for 216 weeks. Follow up.	LY2127399 Q4W Follow Up n=526 participants at risk If participant received LY2127399 in core study: 1 subcutaneous (SC) injection of 120 mg LY2127399 and 1 SC injection of placebo at Week 0, followed by 1 SC injection of 120 mg LY2127399 every 4 weeks (Q4W) for 216 weeks. If participant received placebo in core study: 2 SC injections of 120 mg LY2127399 at week 0, followed by 1 SC injection of 120 mg LY2127399 Q4W for 216 weeks. Follow up.
Gastrointestinal disorders Abdominal pain	2.2% 21/937 • Number of events 21 All randomized participants who received at least 1 dose of study drug.	0.52% 3/578 • Number of events 3 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.96% 9/937 • Number of events 9 All randomized participants who received at least 1 dose of study drug.	2.1% 12/578 • Number of events 12 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	6.3% 59/937 • Number of events 70 All randomized participants who received at least 1 dose of study drug.	3.1% 18/578 • Number of events 21 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.5% 23/937 • Number of events 24 All randomized participants who received at least 1 dose of study drug.	1.2% 7/578 • Number of events 7 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	3.6% 34/937 • Number of events 36 All randomized participants who received at least 1 dose of study drug.	2.1% 12/578 • Number of events 14 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	2.2% 21/937 • Number of events 23 All randomized participants who received at least 1 dose of study drug.	1.7% 10/578 • Number of events 10 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
General disorders Fatigue	2.0% 19/937 • Number of events 20 All randomized participants who received at least 1 dose of study drug.	1.2% 7/578 • Number of events 7 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
General disorders Pyrexia	2.1% 20/937 • Number of events 25 All randomized participants who received at least 1 dose of study drug.	0.69% 4/578 • Number of events 4 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Bronchitis	6.1% 57/937 • Number of events 74 All randomized participants who received at least 1 dose of study drug.	4.5% 26/578 • Number of events 32 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Gastroenteritis	1.5% 14/937 • Number of events 18 All randomized participants who received at least 1 dose of study drug.	2.8% 16/578 • Number of events 16 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	6.7% 63/937 • Number of events 83 All randomized participants who received at least 1 dose of study drug.	6.9% 40/578 • Number of events 46 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Pharyngitis	2.9% 27/937 • Number of events 33 All randomized participants who received at least 1 dose of study drug.	2.6% 15/578 • Number of events 16 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Sinusitis	6.0% 56/937 • Number of events 64 All randomized participants who received at least 1 dose of study drug.	2.9% 17/578 • Number of events 28 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	11.1% 104/937 • Number of events 142 All randomized participants who received at least 1 dose of study drug.	8.8% 51/578 • Number of events 68 All randomized participants who received at least 1 dose of study drug.	2.2% 18/810 • Number of events 18 All randomized participants who received at least 1 dose of study drug.	2.1% 11/526 • Number of events 12 All randomized participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	11.3% 106/937 • Number of events 158 All randomized participants who received at least 1 dose of study drug.	9.0% 52/578 • Number of events 78 All randomized participants who received at least 1 dose of study drug.	2.5% 20/810 • Number of events 21 All randomized participants who received at least 1 dose of study drug.	3.0% 16/526 • Number of events 18 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	3.5% 33/937 • Number of events 39 All randomized participants who received at least 1 dose of study drug.	2.1% 12/578 • Number of events 16 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	3.8% 36/937 • Number of events 39 All randomized participants who received at least 1 dose of study drug.	2.9% 17/578 • Number of events 17 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	2.9% 27/937 • Number of events 29 All randomized participants who received at least 1 dose of study drug.	1.0% 6/578 • Number of events 8 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	1.9% 18/937 • Number of events 19 All randomized participants who received at least 1 dose of study drug.	2.1% 12/578 • Number of events 13 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Nervous system disorders Headache	5.7% 53/937 • Number of events 67 All randomized participants who received at least 1 dose of study drug.	4.8% 28/578 • Number of events 34 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Anxiety	2.2% 21/937 • Number of events 21 All randomized participants who received at least 1 dose of study drug.	1.7% 10/578 • Number of events 11 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Insomnia	1.9% 18/937 • Number of events 18 All randomized participants who received at least 1 dose of study drug.	2.1% 12/578 • Number of events 12 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	3.0% 28/937 • Number of events 29 All randomized participants who received at least 1 dose of study drug.	1.7% 10/578 • Number of events 13 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	2.5% 23/937 • Number of events 28 All randomized participants who received at least 1 dose of study drug.	1.0% 6/578 • Number of events 8 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	2.9% 27/937 • Number of events 27 All randomized participants who received at least 1 dose of study drug.	1.4% 8/578 • Number of events 10 All randomized participants who received at least 1 dose of study drug.	0.00% 0/810 All randomized participants who received at least 1 dose of study drug.	0.00% 0/526 All randomized participants who received at least 1 dose of study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

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

Restriction type: GT60