Trial Outcomes & Findings for Safety and Efficacy Study of Loncastuximab Tesirine + Ibrutinib in Diffuse Large B-Cell or Mantle Cell Lymphoma (NCT NCT03684694)

Last Updated: 2024-02-06

Results Overview

A TEAE was defined as an adverse event (AE) that occurred or worsened in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy, whichever is earlier. Any clinically significant changes form baseline in safety laboratory values, vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, and 12-lead electrocardiograms (ECGs) which occurred after first dose of study drug were recorded as TEAEs.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

136 participants

Primary outcome timeframe

Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total)

Results posted on

2024-02-06

Participant Flow

136 participants were enrolled into sites in the United States, Belgium, France, Italy, and Spain.

Participants were screened for eligibility to enroll within 28 days prior to the start of treatment.

Participant milestones

Participant milestones
Measure	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of PR or SD at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of PR or SD at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1 STARTED	37	4	6	0	0	0
Phase 1 COMPLETED	0	1	1	0	0	0
Phase 1 NOT COMPLETED	37	3	5	0	0	0
Phase 2 STARTED	0	0	0	49	30	10
Phase 2 COMPLETED	0	0	0	0	0	0
Phase 2 NOT COMPLETED	0	0	0	49	30	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of PR or SD at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of PR or SD at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1 Withdrawal by Subject	1	0	0	0	0	0
Phase 1 Investigator/Sponsor Decision	12	2	1	0	0	0
Phase 1 Death	24	0	3	0	0	0
Phase 1 Lost to Follow-up	0	0	1	0	0	0
Phase 1 Miscellaneous	0	1	0	0	0	0
Phase 2 Withdrawal by Subject	0	0	0	0	0	1
Phase 2 Investigator/Sponsor Decision	0	0	0	17	16	6
Phase 2 Death	0	0	0	28	14	3
Phase 2 Lost to Follow-up	0	0	0	1	0	0
Phase 2 Miscellaneous	0	0	0	3	0	0

Baseline Characteristics

Safety and Efficacy Study of Loncastuximab Tesirine + Ibrutinib in Diffuse Large B-Cell or Mantle Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL n=30 Participants Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=37 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=4 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=6 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL n=49 Participants Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL n=10 Participants Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Total n=136 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=21 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=21 Participants	11 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants	5 Participants n=8 Participants	43 Participants n=8 Participants
Age, Categorical >=65 years	20 Participants n=21 Participants	26 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	36 Participants n=4 Participants	5 Participants n=8 Participants	93 Participants n=8 Participants
Sex: Female, Male Female	9 Participants n=21 Participants	10 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	19 Participants n=4 Participants	3 Participants n=8 Participants	45 Participants n=8 Participants
Sex: Female, Male Male	21 Participants n=21 Participants	27 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	30 Participants n=4 Participants	7 Participants n=8 Participants	91 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=21 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=21 Participants	37 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	47 Participants n=4 Participants	9 Participants n=8 Participants	130 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=21 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=8 Participants	4 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=21 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=21 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=21 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=21 Participants	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Race (NIH/OMB) White	26 Participants n=21 Participants	35 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	43 Participants n=4 Participants	10 Participants n=8 Participants	124 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=21 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=21 Participants	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=8 Participants	9 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total)

Population: Measured in the safety population, which included all participants who received study drug.

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=4 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=37 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=6 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	4 Participants	37 Participants	6 Participants	—	—	—

PRIMARY outcome

Timeframe: Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total)

Population: Measured in the safety population, which included all participants who received study drug.

A serious TEAE was defined as any AE which occurred after the first dose of study drug that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance was not considered a serious adverse event), resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or important medical events that did not meet the preceding criteria but based on appropriate medical judgement may have jeopardized the participant or may have required medical or surgical intervention to prevent any of the outcomes listed above.

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=4 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=37 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=6 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1: Number of Participants With Serious TEAEs	0 Participants	19 Participants	3 Participants	—	—	—

PRIMARY outcome

Timeframe: 21 days

Population: Measured in the safety population, which included all participants who received study drug.

A DLT was defined as any of the following events which occur during the DLT Period (first 21 days of ibrutinib treatment), except those that are clearly due to underlying disease or extraneous causes: a hematologic DLT (grade ≥3 anaemia, grade 4/febrile neutropenia, grade ≥3 thrombocytopenia), a non-hematologic DLT (including aspartate aminotransferase \[AST\] and/or alanine aminotransferase \[ALT\] \>3× upper limit of normal (ULN) and bilirubin \>2× ULN), any other non-hematologic toxicities ≥ Grade 3, with exceptions.

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=4 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=37 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=6 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)	0 Participants	0 Participants	2 Participants	—	—	—

PRIMARY outcome

Timeframe: Up to a maximum of 686 days

Population: Measured in the safety population, which included all participants who received study drug.

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=4 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=37 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=6 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1: Number of Participants With Dose Interruptions	0 Participants	1 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Up to a maximum of 686 days

Population: Measured in the safety population, which included all participants who received study drug.

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=4 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=37 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=6 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1: Number of Participants With Dose Reductions	0 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Up to approximately 38 months

Population: Measured in the efficacy analysis set, which included all participants who received at least 1 dose of study drug, who had valid baseline disease assessment(s), and who had at least one valid post-baseline disease assessment. Participants who did not have a post-baseline assessment due to early clinical progression or death (after receiving study drug) were also included.

CRR according to the 2014 Lugano classifications determined by Independent Review Committee (IRC). CRR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR).

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=30 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=48 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=10 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 2: Complete Response Rate (CRR)	26.7 percentage of participants Interval 12.3 to 45.9	27.1 percentage of participants Interval 15.3 to 41.8	90.0 percentage of participants Interval 55.5 to 99.7	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 38 months

ORR according to the 2014 Lugano classification, defined as the percentage of participants with a BOR of CR or partial response (PR).

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=4 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=37 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=6 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1: Overall Response Rate (ORR)	50.0 percentage of participants Interval 6.8 to 93.2	59.5 percentage of participants Interval 42.1 to 75.2	50.0 percentage of participants Interval 11.8 to 88.2	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 36 months

Population: Measured in the efficacy analysis set, which included all participants who received at least 1 dose of study drug, who had valid baseline disease assessment(s), who had at least one valid post-baseline disease assessment who achieved a response. Participants who did not have a post-baseline assessment due to early clinical progression or death (after receiving study drug) were also included.

DOR was defined as the time from the first documentation of tumor response to disease progression or death.

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=2 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=22 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=3 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL n=23 Participants Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL n=14 Participants Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL n=10 Participants Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1 and Phase 2: Duration of Response (DOR)	NA months Data could not be calculated due to insufficient number of participants with events.	7.49 months Interval 2.46 to 20.5	2.50 months Interval 1.94 to Upper confidence interval could not be calculated due to insufficient number of participants with events.	8.25 months Interval 2.3 to Upper confidence interval could not be calculated due to insufficient number of participants with events.	7.64 months Interval 1.87 to Upper confidence interval could not be calculated due to insufficient number of participants with events.	NA months Data could not be calculated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to approximately 36 months

Population: Measured in the efficacy analysis set, which included all participants who received at least 1 dose of study drug, who had valid baseline disease assessment(s), and who had at least one valid post-baseline disease assessment who achieved CR. Participants who did not have a post-baseline assessment due to early clinical progression or death (after receiving study drug) were also included.

RFS was defined as the time from the documentation of CR to disease progression or death.

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=1 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=15 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=2 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL n=13 Participants Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL n=8 Participants Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL n=9 Participants Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1 and Phase 2: Relapse-Free Survival (RFS)	NA months Median, lower and upper confidence interval could not be calculated due to insufficient number of participants with events.	7.49 months Interval 3.61 to 22.28	1.94 months Lower and upper confidence interval could not be calculated due to insufficient number of participants with events.	NA months Median, lower and upper confidence interval could not be calculated due to insufficient number of participants with events.	NA months Median, lower and upper confidence interval could not be calculated due to insufficient number of participants with events.	NA months Median, lower and upper confidence interval could not be calculated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to approximately 37 months

PFS was defined as the time between start of treatment and the first documentation of progression, or death.

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=4 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=37 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=6 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL n=48 Participants Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL n=30 Participants Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL n=10 Participants Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1 and Phase 2: Progression-Free Survival (PFS)	3.17 months Interval 1.22 to Upper confidence interval could not be calculated due to insufficient number of participants with events.	3.55 months Interval 1.74 to 7.79	2.12 months Interval 0.69 to Upper confidence interval could not be calculated due to insufficient number of participants with events.	3.20 months Interval 1.41 to 4.99	3.02 months Interval 1.31 to 6.8	NA months Median, lower and upper confidence interval could not be calculated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to approximately 38 months

OS was defined as the time between the start of treatment and death from any cause.

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=4 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=37 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=6 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL n=48 Participants Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL n=30 Participants Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL n=10 Participants Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1 and Phase 2: Overall Survival (OS)	NA months Median, lower and upper confidence interval could not be calculated due to insufficient number of participants with events.	14.23 months Interval 7.82 to 25.99	NA months Median, lower and upper confidence interval could not be calculated due to insufficient number of participants with events.	8.54 months Interval 4.57 to 20.6	16.76 months Interval 7.16 to Upper confidence interval could not be calculated due to insufficient number of participants with events.	NA months Median, lower and upper confidence interval could not be calculated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: C1D1 pre-dose, EOI, 4h PD, C1D8 168h PD, C1D15 336h PD, C2D1 pre-dose, EOI, 4h PD, C2D8 168h PD, C2D15 336h PD (3 week cycles)

Population: Measured in the PK population, which included all participants who had at least 1 pre-C1D1 and 1 post-dose valid PK assessment. The "number of participants analzyed" represents the number of participants with collected data. Analysis reported per dose of loncastuximab tesirine as pre-specified.

Blood samples were collected for analysis of PK data of loncastuximab tesirine (total antibody, PBD-conjugated antibody and unconjugated cytotoxin SG3199)

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=4 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=124 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=6 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1 and Phase 2: Time to Reach Maximum Concentration (Tmax) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 1: PBD-conjugated Antibody	0.0410 days Geometric Coefficient of Variation 118	0.0410 days Geometric Coefficient of Variation 122	0.0330 days Geometric Coefficient of Variation 108	—	—	—
Phase 1 and Phase 2: Time to Reach Maximum Concentration (Tmax) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 1: Total Antibody	0.0410 days Geometric Coefficient of Variation 118	0.0420 days Geometric Coefficient of Variation 125	0.0250 days Geometric Coefficient of Variation 21.1	—	—	—
Phase 1 and Phase 2: Time to Reach Maximum Concentration (Tmax) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 1: Unconjugated cytotoxin SG3199	—	14.9 days Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable data.	6.94 days Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable data.	—	—	—
Phase 1 and Phase 2: Time to Reach Maximum Concentration (Tmax) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 2: PBD-conjugated Antibody	0.164 days Geometric Coefficient of Variation 3347	0.0470 days Geometric Coefficient of Variation 223	0.0280 days Geometric Coefficient of Variation 37.8	—	—	—
Phase 1 and Phase 2: Time to Reach Maximum Concentration (Tmax) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 2: Total Antibody	0.0370 days Geometric Coefficient of Variation 136	0.0570 days Geometric Coefficient of Variation 232	0.0280 days Geometric Coefficient of Variation 37.8	—	—	—
Phase 1 and Phase 2: Time to Reach Maximum Concentration (Tmax) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 2: Unconjugated cytotoxin SG3199	—	0.0220 days Geometric Coefficient of Variation 19.9	—	—	—	—

SECONDARY outcome

Timeframe: C1D1 pre-dose, EOI, 4h PD, C1D8 168h PD, C1D15 336h PD, C2D1 pre-dose, EOI, 4h PD, C2D8 168h PD, C2D15 336h PD (3 week cycles)

Blood samples were collected for analysis of PK data of loncastuximab tesirine (total antibody, PBD-conjugated antibody and unconjugated cytotoxin SG3199)

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=4 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=124 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=6 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1 and Phase 2: Maximum Observed Concentration (Cmax) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 1: PBD-conjugated Antibody	872 ng/mL Geometric Coefficient of Variation 23.8	753 ng/mL Geometric Coefficient of Variation 52.7	1065 ng/mL Geometric Coefficient of Variation 17.0	—	—	—
Phase 1 and Phase 2: Maximum Observed Concentration (Cmax) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 1: Total Antibody	1270 ng/mL Geometric Coefficient of Variation 29.0	1192 ng/mL Geometric Coefficient of Variation 55.1	2073 ng/mL Geometric Coefficient of Variation 23.5	—	—	—
Phase 1 and Phase 2: Maximum Observed Concentration (Cmax) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 1: Unconjugated cytotoxin SG3199	—	0.0260 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable data.	0.0480 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable data.	—	—	—
Phase 1 and Phase 2: Maximum Observed Concentration (Cmax) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 2: PBD-conjugated Antibody	628 ng/mL Geometric Coefficient of Variation 63.1	815 ng/mL Geometric Coefficient of Variation 67.0	1111 ng/mL Geometric Coefficient of Variation 7.48	—	—	—
Phase 1 and Phase 2: Maximum Observed Concentration (Cmax) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 2: Total Antibody	944 ng/mL Geometric Coefficient of Variation 68.8	1328 ng/mL Geometric Coefficient of Variation 65.0	1996 ng/mL Geometric Coefficient of Variation 18.2	—	—	—
Phase 1 and Phase 2: Maximum Observed Concentration (Cmax) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 2: Unconjugated cytotoxin SG3199	—	0.0450 ng/mL Geometric Coefficient of Variation 85.4	—	—	—	—

SECONDARY outcome

Timeframe: C1D1 pre-dose, EOI, 4h PD, C1D8 168h PD, C1D15 336h PD, C2D1 pre-dose, EOI, 4h PD, C2D8 168h PD, C2D15 336h PD (3 week cycles)

Blood samples were collected for analysis of PK data of loncastuximab tesirine (total antibody, PBD-conjugated antibody and unconjugated cytotoxin SG3199)

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=4 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=124 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=6 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1 and Phase 2: Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 1: PBD-conjugated Antibody	5899 day*ng/mL Geometric Coefficient of Variation 34.3	3711 day*ng/mL Geometric Coefficient of Variation 237	5772 day*ng/mL Geometric Coefficient of Variation 50.0	—	—	—
Phase 1 and Phase 2: Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 1: Total Antibody	8364 day*ng/mL Geometric Coefficient of Variation 48.6	5528 day*ng/mL Geometric Coefficient of Variation 244	9877 day*ng/mL Geometric Coefficient of Variation 56.0	—	—	—
Phase 1 and Phase 2: Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 1: Unconjugated cytotoxin SG3199	—	0.105 day*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable data.	0.481 day*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable data.	—	—	—
Phase 1 and Phase 2: Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 2: PBD-conjugated Antibody	5681 day*ng/mL Geometric Coefficient of Variation 52.4	3200 day*ng/mL Geometric Coefficient of Variation 530	8503 day*ng/mL Geometric Coefficient of Variation 24.2	—	—	—
Phase 1 and Phase 2: Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 2: Total Antibody	8828 day*ng/mL Geometric Coefficient of Variation 63.0	4798 day*ng/mL Geometric Coefficient of Variation 565	15785 day*ng/mL Geometric Coefficient of Variation 30.0	—	—	—
Phase 1 and Phase 2: Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 2: Unconjugated cytotoxin SG3199	—	0.00700 day*ng/mL Geometric Coefficient of Variation 1118314	—	—	—	—

SECONDARY outcome

Timeframe: C1D1 pre-dose, EOI, 4h PD, C1D8 168h PD, C1D15 336h PD, C2D1 pre-dose, EOI, 4h PD, C2D8 168h PD, C2D15 336h PD (3 week cycles)

Blood samples were collected for analysis of PK data of loncastuximab tesirine (total antibody, PBD-conjugated antibody and unconjugated cytotoxin SG3199).

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=1 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=78 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=2 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1 and Phase 2: Area Under the Concentration-Time Curve From Time Zero to the End of the Dosing Interval (AUCtau) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 2: PBD-conjugated Antibody	6800 day*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable data.	6785 day*ng/mL Geometric Coefficient of Variation 55.0	9084 day*ng/mL Geometric Coefficient of Variation 26.7	—	—	—
Phase 1 and Phase 2: Area Under the Concentration-Time Curve From Time Zero to the End of the Dosing Interval (AUCtau) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 2: Total Antibody	12419 day*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable data.	11228 day*ng/mL Geometric Coefficient of Variation 47.6	18090 day*ng/mL Geometric Coefficient of Variation 29.6	—	—	—

SECONDARY outcome

Timeframe: C1D1 pre-dose, EOI, 4h PD, C1D8 168h PD, C1D15 336h PD, C2D1 pre-dose, EOI, 4h PD, C2D8 168h PD, C2D15 336h PD (3 week cycles)

Blood samples were collected for analysis of PK data of loncastuximab tesirine (total antibody, PBD-conjugated antibody and unconjugated cytotoxin SG3199).

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=2 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=45 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=3 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1 and Phase 2: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 1: PBD-conjugated Antibody	5197 day*ng/mL Geometric Coefficient of Variation 7.00	4766 day*ng/mL Geometric Coefficient of Variation 47.1	5511 day*ng/mL Geometric Coefficient of Variation 65.6	—	—	—
Phase 1 and Phase 2: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 1: Total Antibody	—	8153 day*ng/mL Geometric Coefficient of Variation 35.6	11397 day*ng/mL Geometric Coefficient of Variation 48.8	—	—	—

SECONDARY outcome

Timeframe: C1D1 pre-dose, EOI, 4h PD, C1D8 168h PD, C1D15 336h PD, C2D1 pre-dose, EOI, 4h PD, C2D8 168h PD, C2D15 336h PD (3 week cycles)

Blood samples were collected for analysis of PK data of loncastuximab tesirine (total antibody, PBD-conjugated antibody and unconjugated cytotoxin SG3199).

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=2 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=78 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=3 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1 and Phase 2: Clearance (CL) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 1: PBD-conjugated Antibody	0.848 L/day Geometric Coefficient of Variation 5.00	0.751 L/day Geometric Coefficient of Variation 47.2	1.06 L/day Geometric Coefficient of Variation 96.8	—	—	—
Phase 1 and Phase 2: Clearance (CL) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 1: Total Antibody	—	0.548 L/day Geometric Coefficient of Variation 34.5	0.639 L/day Geometric Coefficient of Variation 85.2	—	—	—
Phase 1 and Phase 2: Clearance (CL) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 2: PBD-conjugated Antibody	0.597 L/day Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable data.	0.548 L/day Geometric Coefficient of Variation 51.4	0.635 L/day Geometric Coefficient of Variation 69.0	—	—	—
Phase 1 and Phase 2: Clearance (CL) of Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 2: Total Antibody	0.395 L/day Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable data.	0.401 L/day Geometric Coefficient of Variation 43.6	0.385 L/day Geometric Coefficient of Variation 72.6	—	—	—

SECONDARY outcome

Timeframe: C1D1 pre-dose, EOI, 4h PD, C1D8 168h PD, C1D15 336h PD, C2D1 pre-dose, EOI, 4h PD, C2D8 168h PD, C2D15 336h PD (3 week cycles)

Blood samples were collected for analysis of PK data of loncastuximab tesirine (total antibody, PBD-conjugated antibody and unconjugated cytotoxin SG3199).

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=1 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=65 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=2 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1 and Phase 2: Accumulation Index (AI) Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 2: PBD-conjugated Antibody	1.15 ratio Geometric Coefficient of Variation NA Geometric coefficient of variation could not be calculated as there was only 1 participant with evaluable data.	1.43 ratio Geometric Coefficient of Variation 24.6	1.47 ratio Geometric Coefficient of Variation 48.4	—	—	—
Phase 1 and Phase 2: Accumulation Index (AI) Loncastuximab Tesirine (Total Antibody, PBD-Conjugated Antibody and Unconjugated Cytotoxin SG3199) Cycle 2: Total Antibody	—	1.39 ratio Geometric Coefficient of Variation 23.3	1.36 ratio Geometric Coefficient of Variation 33.8	—	—	—

SECONDARY outcome

Timeframe: Up to a maximum of 711 days

Population: ADA-evaluable participants including all participants tested for ADAs in the study.

Detection of ADAs was performed by using a screening assay for identification of antibody positive samples/participants, a confirmation assay, and titer assessment.

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=4 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=37 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=6 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL n=48 Participants Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL n=29 Participants Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL n=10 Participants Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 1 and Phase 2: Number of Participants With Positive Anti-Drug Antibody (ADA) Titers to Loncastuximab Tesirine at Any Time	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to approximately 38 months

ORR according to the 2014 Lugano classification, defined as the percentage of participants with a BOR of CR or PR.

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=30 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=48 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=10 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 2: ORR	46.7 percentage of participants Interval 28.3 to 65.7	47.9 percentage of participants Interval 33.3 to 62.8	100 percentage of participants Interval 69.2 to 100.0	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 38 months

CRR according to the 2014 Lugano classifications determined by the IRC. CRR was defined as the percentage of participants with a BOR of CR in non-GCB DLBCL, GCB DLBCL, all DLBCL, and MCL participants.

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=30 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=48 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=10 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL n=78 Participants Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 2: CRR in Non-GCB DLBCL, GCB DLBCL, All DLBCL and MCL Participants	26.7 percentage of participants Interval 12.3 to 45.9	27.1 percentage of participants Interval 15.3 to 41.8	90.0 percentage of participants Interval 55.5 to 99.7	26.9 percentage of participants Interval 17.5 to 38.2	—	—

SECONDARY outcome

Timeframe: Day 1 until 30 days after last dose; max duration of treatment was 711 days for Phase 2 (up to approximately 741 days total)

Population: Measured in the safety population, which included all participants who received study drug.

A TEAE was defined as an adverse event (AE) that occurred or worsened in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy, whichever is earlier. Any clinically significant changes form baseline in safety laboratory values, vital signs, ECOG performance status, and 12-lead ECGs which occurred after first dose of study drug were recorded as TEAEs.

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=30 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=49 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=10 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 2: Number of Participants With TEAEs	30 Participants	48 Participants	10 Participants	—	—	—

SECONDARY outcome

Timeframe: Day 1 until 30 days after last dose; max duration of treatment was 711 days for Phase 2 (up to approximately 741 days total)

Population: Measured in the safety population, which included all participants who received study drug.

Outcome measures

Outcome measures
Measure	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=30 Participants Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=49 Participants Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=10 Participants Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Phase 2: Number of Participants With Serious TEAEs	5 Participants	27 Participants	5 Participants	—	—	—

Adverse Events

Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib

Serious events: 19 serious events

Other events: 37 other events

Deaths: 24 deaths

Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib

Serious events: 3 serious events

Other events: 6 other events

Deaths: 3 deaths

Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL

Serious events: 27 serious events

Other events: 48 other events

Deaths: 28 deaths

Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL

Serious events: 5 serious events

Other events: 30 other events

Deaths: 14 deaths

Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL

Serious events: 5 serious events

Other events: 10 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=37 participants at risk Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=4 participants at risk Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=6 participants at risk Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL n=49 participants at risk Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL n=30 participants at risk Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL n=10 participants at risk Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Blood and lymphatic system disorders Neutropenia	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Blood and lymphatic system disorders Febrile neutropenia	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Blood and lymphatic system disorders Lymph node pain	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Blood and lymphatic system disorders Haemorrhagic disorder	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Cardiac disorders Atrial fibrillation	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Cardiac disorders Pericardial effusion	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Cardiac disorders Cardiomyopathy	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Cardiac disorders Cardiopulmonary failure	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Cardiac disorders Coronary artery disease	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Cardiac disorders Pericardial disease	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Cardiac disorders Pericarditis	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Abdominal pain upper	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Ascites	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Stomatitis	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Vomiting	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Colitis	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Death	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Asthenia	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Oedema peripheral	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders General physical health deterioration	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	8.2% 4/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Disease progression	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Corona virus infection	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Citrobacter infection	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Enterococcal infection	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Folliculitis	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Pneumocystis jirovecii infection	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Pneumonia	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Pneumonia fungal	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Progressive multifocal leukoencephalopathy	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Urinary tract infection bacterial	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Pneumonia viral	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.2% 5/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Sepsis	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Urinary tract infection	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Bacteraemia	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Campylobacter infection	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Escherichia sepsis	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Pneumonia parainfluenzae viral	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Urosepsis	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Injury, poisoning and procedural complications Fall	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Injury, poisoning and procedural complications Humerus fracture	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Investigations Transaminases increased	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Bone swelling	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Nervous system disorders Ataxia	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Psychiatric disorders Delirium	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Renal and urinary disorders Acute kidney injury	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Renal and urinary disorders Haematuria	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Renal and urinary disorders Renal failure	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Lung disorder	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Vascular disorders Deep vein thrombosis	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Vascular disorders Hypotension	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.

Other adverse events

Other adverse events
Measure	Phase 1: 60 µg/kg Loncastuximab Tesirine and Ibrutinib n=37 participants at risk Participants with advanced diffuse large B-Cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) were enrolled to receive 60 µg/kg of loncastuximab tesirine via intravenous (IV) infusion once every 3 weeks (Q3W) for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 75 µg/kg Loncastuximab Tesirine and Ibrutinib n=4 participants at risk Participants with advanced DLBCL or MCL were enrolled to receive 75 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 1: 90 µg/kg Loncastuximab Tesirine and Ibrutinib n=6 participants at risk Participants with advanced DLBCL or MCL were enrolled to receive 90 µg/kg of loncastuximab tesirine via IV infusion Q3W for 2 treatment cycles (cycle is 3 weeks for Cycles 1 and 2) with concurrent 560 mg ibrutinib orally via capsules once daily. Participants who had a response of partial response (PR) or stable disease (SD) at the 14-week assessment may have received 2 additional doses of loncastuximab tesirine given 4 weeks apart on Day 1 of Cycles 5 and 6.	Phase 2: Loncastuximab Tesirine and Ibrutinib in Non-Germinal Center B-cell (GCB) DLBCL n=49 participants at risk Participants with non-germinal center B-cell (GCB) DLBCL received the recommended phase 2 dose (RP2D) of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of complete response (CR), partial response (PR), and stable disease (SD) received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in GCB DLBCL n=30 participants at risk Participants with GCB DLBCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.	Phase 2: Loncastuximab Tesirine and Ibrutinib in MCL n=10 participants at risk Participants with MCL received the RP2D of 60 µg/kg loncastuximab tesirine via IV infusion with concurrent 560 mg ibrutinib orally via capsules once daily. Loncastuximab tesirine was administered on Day 1 of Cycles 1 and 2 (cycle is 3 weeks for Cycles 1 and 2, and 4 weeks for Cycles 3 onwards). Participants who had a response of CR, PR, and SD received additional doses of loncastuximab tesirine on Day 1 of Cycles 5, 6, 9 and 10.
Blood and lymphatic system disorders Thrombocytopenia	45.9% 17/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	50.0% 2/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	66.7% 4/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	44.9% 22/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	40.0% 12/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	40.0% 4/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Blood and lymphatic system disorders Anaemia	24.3% 9/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	50.0% 2/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	66.7% 4/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	26.5% 13/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	13.3% 4/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Blood and lymphatic system disorders Neutropenia	13.5% 5/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	75.0% 3/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	36.7% 18/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	23.3% 7/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	40.0% 4/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Blood and lymphatic system disorders Leukopenia	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	8.2% 4/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	13.3% 4/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Blood and lymphatic system disorders Lymphopenia	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Cardiac disorders Atrial fibrillation	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	8.2% 4/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Cardiac disorders Sinus bradycardia	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Cardiac disorders Sinus tachycardia	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Cardiac disorders Tachycardia	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Cardiac disorders Palpitations	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	20.0% 2/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Cardiac disorders Acute coronary syndrome	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Cardiac disorders Bradycardia	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Ear and labyrinth disorders Vertigo	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Eye disorders Swelling of eyelid	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Eye disorders Vision blurred	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Eye disorders Ocular hyperaemia	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Eye disorders Cataract	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Diarrhoea	24.3% 9/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	50.0% 2/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	18.4% 9/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	23.3% 7/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	50.0% 5/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Nausea	24.3% 9/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.2% 5/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	13.3% 4/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Constipation	10.8% 4/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	12.2% 6/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Dyspepsia	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.1% 3/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Vomiting	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.2% 5/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 3/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Abdominal pain	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.1% 3/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 3/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Stomatitis	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Dry mouth	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Faeces soft	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Gastritis	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 3/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Dysphagia	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Pancreatitis	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Odynophagia	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Gastrointestinal disorders Oral pain	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Fatigue	24.3% 9/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	33.3% 2/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	28.6% 14/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	30.0% 3/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Oedema peripheral	16.2% 6/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	24.5% 12/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 3/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Asthenia	16.2% 6/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.2% 5/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	30.0% 3/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Pyrexia	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	33.3% 2/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	20.4% 10/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Chills	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Early satiety	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Malaise	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Mucosal inflammation	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Pain	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Sensation of foreign body	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Peripheral swelling	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Chest pain	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
General disorders Generalised oedema	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Hepatobiliary disorders Hepatocellular injury	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	20.0% 2/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Hepatobiliary disorders Bile duct stone	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Hepatobiliary disorders Cholecystocholangitis	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Immune system disorders Hypogammaglobulinaemia	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Conjunctivitis	16.2% 6/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	20.0% 2/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Oral candidiasis	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Pneumonia	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Urinary tract infection	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 3/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	20.0% 2/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Corona virus infection	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.1% 3/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Furuncle	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Sinusitis	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Herpes zoster	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Lung infection	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Oral fungal infection	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Pharyngitis	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	20.0% 2/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Rhinitis	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Bronchitis	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Eye infection	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Oral herpes	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Clostridium difficile colitis	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Erysipelas	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Genital infection fungal	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Infections and infestations Upper respiratory tract infection	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Injury, poisoning and procedural complications Fall	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Injury, poisoning and procedural complications Skin abrasion	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Injury, poisoning and procedural complications Contusion	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Injury, poisoning and procedural complications Limb injury	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Investigations Alanine aminotransferase increased	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	50.0% 3/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	8.2% 4/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 3/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Investigations Gamma-glutamyltransferase increased	10.8% 4/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	33.3% 2/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.1% 3/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	20.0% 2/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Investigations Lipase increased	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Investigations Weight increased	10.8% 4/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.1% 3/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Investigations Weight decreased	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Investigations Amylase increased	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	8.2% 4/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 3/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Investigations Blood bilirubin increased	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.1% 3/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Investigations Blood creatinine increased	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Investigations Blood iron decreased	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Investigations Aspartate aminotransferase increased	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	33.3% 2/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.2% 5/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 3/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Investigations Coronavirus test positive	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Metabolism and nutrition disorders Hypokalaemia	16.2% 6/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	12.2% 6/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 3/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Metabolism and nutrition disorders Decreased appetite	13.5% 5/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	8.2% 4/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	20.0% 2/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Metabolism and nutrition disorders Hypomagnesaemia	13.5% 5/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	12.2% 6/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Metabolism and nutrition disorders Hypophosphataemia	10.8% 4/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	14.3% 7/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	20.0% 6/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Metabolism and nutrition disorders Hypocalcaemia	10.8% 4/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.2% 5/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	13.3% 4/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Metabolism and nutrition disorders Hypercalcaemia	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Metabolism and nutrition disorders Hyperkalaemia	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Metabolism and nutrition disorders Hyperglycaemia	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	30.0% 3/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Metabolism and nutrition disorders Hyponatraemia	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.1% 3/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Metabolism and nutrition disorders Hypermagnesaemia	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 3/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Arthralgia	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	12.2% 6/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	20.0% 2/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Back pain	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	12.2% 6/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Metabolism and nutrition disorders Musculoskeletal pain	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	8.2% 4/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Nervous system disorders Headache	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	8.2% 4/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Nervous system disorders Dizziness	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Nervous system disorders Paraesthesia	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Nervous system disorders Neuropathy peripheral	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	20.0% 2/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Nervous system disorders Ataxia	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Psychiatric disorders Anxiety	10.8% 4/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Psychiatric disorders Insomnia	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	8.2% 4/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Psychiatric disorders Agitation	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Psychiatric disorders Depression	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Psychiatric disorders Confusional state	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Renal and urinary disorders Dysuria	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Cough	16.2% 6/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	12.2% 6/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	12.2% 6/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Rash	18.9% 7/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	12.2% 6/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	13.3% 4/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	20.0% 2/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Dermatitis bullous	10.8% 4/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Pruritus	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	8.2% 4/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	30.0% 3/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Dry skin	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	20.0% 2/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Erythema	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.2% 5/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 5/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	30.0% 3/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Petechiae	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 3/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Photosensitivity reaction	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	16.7% 1/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Blister	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Purpura	5.4% 2/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	25.0% 1/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Night sweats	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Ecchymosis	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Lividity	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Macule	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Palmar erythema	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Rash vesicular	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Skin and subcutaneous tissue disorders Skin ulcer	2.7% 1/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Vascular disorders Hypertension	10.8% 4/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	4.1% 2/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	3.3% 1/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	30.0% 3/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Vascular disorders Haematoma	8.1% 3/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	2.0% 1/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Vascular disorders Flushing	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	6.7% 2/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.
Vascular disorders Phlebitis	0.00% 0/37 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/4 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/6 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/49 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	0.00% 0/30 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.	10.0% 1/10 • All-cause mortality reporting was from enrollment until approximately 4 years. For serious adverse events and other adverse events, from Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total), 711 days for Phase 2 (up to approximately 741 days total). Measured in the safety population, which included all participants who received study drug.

Additional Information

Clinical Trials Information

ADC Therapeutics SA

Phone: 954-903-7994

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI can publish after first multi-site publication or if no multi-site publication is made within 18 months of study completion/termination. The only disclosure restriction on PI is sponsor can review results comms. prior to public release and can embargo comms. Regarding trial results for a period \>60 but ≤180 days from time submitted to sponsor review. Sponsor can't require changes to the comms, extend embargo or require changes to comms, except removing confidential info that are not results.
Publication restrictions are in place

Restriction type: OTHER