Trial Outcomes & Findings for A Study of Weekly Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With Safety Run-in (innovaTV 208) (NCT NCT03657043)

NCT ID: NCT03657043

Last Updated: 2023-05-06

Results Overview

Incidence of dose-limiting toxicity (DLT) was evaluated in participants enrolled in the Safety Run-In, who were followed for protocol-defined DLT events up to 28 days after the first dose of tisotumab vedotin.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 98 participants
• Primary outcome timeframe: Up to 28 days
• Results posted on: 2023-05-06

Participant Flow

A total of 98 participants were enrolled into the Safety Run-In and Part B Expansion cohorts, of which 94 received study drug. No participants were enrolled into Part A.

Participant milestones

Measure	Safety Run-In 0.9 mg/kg 3Q4W Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Part A Q3W Tisotumab Vedotin 2.0 mg/kg by IV infusion on Day 1 of each 3-week treatment cycle	Part A 3Q4W Tisotumab Vedotin by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Part B Expansion Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Overall Study STARTED	8	8	0	0	82
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	8	8	0	0	82

Reasons for withdrawal

Measure	Safety Run-In 0.9 mg/kg 3Q4W Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Part A Q3W Tisotumab Vedotin 2.0 mg/kg by IV infusion on Day 1 of each 3-week treatment cycle	Part A 3Q4W Tisotumab Vedotin by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Part B Expansion Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Overall Study Withdrawal by Subject	1	1	0	0	4
Overall Study Study closure by Sponsor	0	2	0	0	17
Overall Study Lost to Follow-up	0	0	0	0	4
Overall Study Death	6	5	0	0	53
Overall Study Met exclusion criteria after enrollment	1	0	0	0	0
Overall Study Adverse Event	0	0	0	0	2
Overall Study Withdrawal - subsequent treatment	0	0	0	0	1
Overall Study Withdrawal - declined follow-up	0	0	0	0	1

Baseline Characteristics

A Study of Weekly Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With Safety Run-in (innovaTV 208)

Baseline characteristics by cohort

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=7 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W n=8 Participants Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Part B Expansion n=79 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Total n=94 Participants Total of all reporting groups
Age, Continuous	69.0 Years n=93 Participants	67.5 Years n=4 Participants	60.0 Years n=27 Participants	62.0 Years n=483 Participants
Sex/Gender, Customized Female	7 Participants n=93 Participants	8 Participants n=4 Participants	79 Participants n=27 Participants	94 Participants n=483 Participants
Sex/Gender, Customized Intersex	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants	4 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	6 Participants n=27 Participants	7 Participants n=483 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants	6 Participants n=4 Participants	69 Participants n=27 Participants	81 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race/Ethnicity, Customized Hispanic or Latino/a, or of Spanish Origin	0 Participants n=93 Participants	1 Participants n=4 Participants	9 Participants n=27 Participants	10 Participants n=483 Participants
Race/Ethnicity, Customized Not of Hispanic or Latino/a, or of Spanish Origin	6 Participants n=93 Participants	7 Participants n=4 Participants	69 Participants n=27 Participants	82 Participants n=483 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Score Grade 0	4 Participants n=93 Participants	5 Participants n=4 Participants	48 Participants n=27 Participants	57 Participants n=483 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Score Grade 1	3 Participants n=93 Participants	3 Participants n=4 Participants	31 Participants n=27 Participants	37 Participants n=483 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: Participants from the Safety Analysis Set that were enrolled in the Safety Run-In. The Safety Analysis Set includes all participants who received any amount of study drug.

Incidence of dose-limiting toxicity (DLT) was evaluated in participants enrolled in the Safety Run-In, who were followed for protocol-defined DLT events up to 28 days after the first dose of tisotumab vedotin.

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=7 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W n=8 Participants Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Number of Participants With Dose-Limiting Toxicities (DLTs) (Safety Run-In Only)	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to 9.7 months

Population: The Full Analysis Set includes all participants who received any amount of study drug.

Proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=79 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Confirmed Objective Response Rate (ORR) (Part B)	7 Participants	—

SECONDARY outcome

Timeframe: Up to 23.0 months

Population: The Safety Analysis Set includes all participants who received any amount of study drug.

An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment.

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=79 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Number of Participants With Adverse Events (AEs) (Part B) Any TEAE	79 Participants	—
Number of Participants With Adverse Events (AEs) (Part B) Treatment-related TEAE	67 Participants	—
Number of Participants With Adverse Events (AEs) (Part B) Treatment-related Grade 3-4 TEAE	14 Participants	—
Number of Participants With Adverse Events (AEs) (Part B) Treatment-related Grade 5 TEAE	0 Participants	—
Number of Participants With Adverse Events (AEs) (Part B) Max severity of TEAE - Grade 1	7 Participants	—
Number of Participants With Adverse Events (AEs) (Part B) Max severity of TEAE - Grade 2	35 Participants	—
Number of Participants With Adverse Events (AEs) (Part B) Max severity of TEAE - Grade 3	32 Participants	—
Number of Participants With Adverse Events (AEs) (Part B) Max severity of TEAE - Grade 4	3 Participants	—
Number of Participants With Adverse Events (AEs) (Part B) Max severity of TEAE - Grade 5	2 Participants	—
Number of Participants With Adverse Events (AEs) (Part B) Any treatment-emergent serious AE (SAE)	28 Participants	—
Number of Participants With Adverse Events (AEs) (Part B) Treatment-related SAE	6 Participants	—

SECONDARY outcome

Timeframe: Up to 9.7 months

Population: The Full Analysis Set includes all participants who received any amount of study drug.

Proportion of participants who achieve a CR or PR according to RECIST v1.1 as assessed by the investigator

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=79 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Confirmed and Unconfirmed ORR (Part B)	18.0 Percentage of Participants Interval 10.0 to 27.9	—

SECONDARY outcome

Timeframe: Up to 10.1 months

Population: The CA-125 evaluable analysis set includes participants who have an elevated baseline CA-125 value of ≥2 x ULN (upper limit of normal) within 2 weeks prior to the first dose of study drug.

Percentage of participants who have at least a 50% reduction in CA-125 value from baseline

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=51 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Cancer Antigen 125 (CA-125) Response Rate According to Gynecologic Cancer Intergroup (GCIG) Criteria (Part B)	12.0 Percentage of Participants Interval 4.4 to 23.9	—

SECONDARY outcome

Timeframe: Up to 10.1 months

Population: The Full Analysis Set includes all participants who received any amount of study drug.

Percentage of participants whose best response is a CR or PR according to the GCIG combined RECIST and CA-125 criteria

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=79 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Overall Response According to the Gynecological Cancer Intergroup (GCIG) Combined RECIST and CA-125 Criteria (Part B)	11.0 Percentage of Participants Interval 5.3 to 20.5	—

SECONDARY outcome

Timeframe: Up to 8.3 months

Population: Subset of the Full Analysis Set includes all participants who received any amount of study drug and had a confirmed CR or PR.

Time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD or death due to any cause, whichever comes first

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=7 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Duration of Response (DOR) (Part B)	4.21 Months Interval 3.02 to Upper limit not available, insufficient number of events.	—

SECONDARY outcome

Timeframe: Up to 3.0 months

Population: The Full Analysis Set includes all participants who received any amount of study drug

Percentage of participants who achieved a confirmed Complete Response(CR) or Partial Response (PR) per RECIST v1.1 as assessed by the investigator, or meet the Stable Disease (SD) criteria at least once after start of study treatment at a minimum interval of 12 weeks.

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=79 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Disease Control Rate (DCR) (Part B)	54.4 Percentage of Participants Interval 42.8 to 65.7	—

SECONDARY outcome

Timeframe: Up to 23.0 months

Population: Subset of the Full Analysis Set includes all participants who received any amount of study drug and had a confirmed CR or PR.

Time from the start of study treatment to the first documentation of objective response (CR or PR that is subsequently confirmed)

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=7 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Time to Response (TTR) (Part B)	1.4 Months Interval 1.0 to 3.0	—

SECONDARY outcome

Timeframe: Up to 9.7 months

Population: The Full Analysis Set includes all participants who received any amount of study drug.

Time from the start of study treatment to the first documentation of PD or death due to any cause, whichever comes first

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=79 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Progression-free Survival (PFS) (Part B)	2.73 Months Interval 1.64 to 2.99	—

SECONDARY outcome

Timeframe: Up to 23.0 months

Population: The Full Analysis Set includes all participants who received any amount of study drug.

Time from the start of study treatment to date of death due to any cause

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=79 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Overall Survival (OS) (Part B)	10.68 Months Interval 7.75 to 12.81	—

SECONDARY outcome

Timeframe: Up to 6.9 months

Population: Participants in the Safety Analysis Set with a baseline and at least one post-baseline ATA sample.

The proportion of participants who develop ATA at any time during the study. A positive baseline ATA result is considered positive post-baseline if the post-baseline ATA titer result is at least four times higher than the baseline result.

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=71 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Incidence of Antitherapeutic Antibodies (ATA) (Part B) Baseline Negative - Negative post-baseline	65 Participants	—
Incidence of Antitherapeutic Antibodies (ATA) (Part B) Baseline Negative - Positive post-baseline	3 Participants	—
Incidence of Antitherapeutic Antibodies (ATA) (Part B) Baseline Positive - Negative post-baseline	3 Participants	—
Incidence of Antitherapeutic Antibodies (ATA) (Part B) Baseline Positive - Positive post-baseline	0 Participants	—

SECONDARY outcome

Timeframe: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.

Population: PK analysis set which includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated.

ADC Cmax was derived from the PK blood samples collected.

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=77 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Pharmacokinetic (PK) Parameter: Antibody-Drug Conjugate (ADC) Maximum Concentration (Cmax) (Part B) Cycle 1, Dose 1	20.582 µg/mL Geometric Coefficient of Variation 26.963	—
Pharmacokinetic (PK) Parameter: Antibody-Drug Conjugate (ADC) Maximum Concentration (Cmax) (Part B) Cycle 1, Dose 3	21.817 µg/mL Geometric Coefficient of Variation 26.823	—

SECONDARY outcome

Timeframe: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.

Population: PK analysis set which includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated.

ADC Tmax was derived from the PK blood samples collected.

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=77 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
PK Parameter: ADC Time of Cmax (Tmax) (Part B) Cycle 1, Dose 1	0.041 Days Geometric Coefficient of Variation 53.112	—
PK Parameter: ADC Time of Cmax (Tmax) (Part B) Cycle 1, Dose 3	0.041 Days Geometric Coefficient of Variation 78.407	—

SECONDARY outcome

Timeframe: Cycle 1 Dose 1 AUC 7: Assessed from Cycle 1 Days 1 - 8 (predose). Cycle 1 Dose 3 AUC 7: Assessed from Cycle 1 Days 15 - 22. Cycle 1 Dose 3 AUC 14: Assessed from Cycle 1 Days 15 - Cycle 2 Day 1 (predose).

Population: PK Analysis Set includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated.

ADC AUC was derived from the PK blood samples collected.

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=77 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
PK Parameter: ADC Area Under Concentration-Time Curve (AUC) (Part B) Cycle 1, Dose 1 - AUC 7 Days-ADC	25.198 µg/mL*day Geometric Coefficient of Variation 25.335	—
PK Parameter: ADC Area Under Concentration-Time Curve (AUC) (Part B) Cycle 1, Dose 3 - AUC 7 Days-ADC	30.159 µg/mL*day Geometric Coefficient of Variation 32.261	—
PK Parameter: ADC Area Under Concentration-Time Curve (AUC) (Part B) Cycle 1, Dose 3 - AUC 14 Days-ADC	31.716 µg/mL*day Geometric Coefficient of Variation 31.632	—

SECONDARY outcome

Timeframe: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.

Population: PK analysis set which includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated.

MMAE Cmax was derived from the PK blood samples collected.

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=77 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
PK Parameter: Free Monomethyl Auristatin E (MMAE) Cmax (Part B) Cycle 1, Dose 1	1.778 ng/mL Geometric Coefficient of Variation 66.636	—
PK Parameter: Free Monomethyl Auristatin E (MMAE) Cmax (Part B) Cycle 1, Dose 3	2.552 ng/mL Geometric Coefficient of Variation 52.442	—

SECONDARY outcome

Timeframe: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.

Population: PK analysis set which includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated.

MMAE Tmax was derived from the PK blood samples collected.

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=77 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
PK Parameter: MMAE Tmax (Part B) Cycle 1, Dose 1	2.061 Days Geometric Coefficient of Variation 26.838	—
PK Parameter: MMAE Tmax (Part B) Cycle 1, Dose 3	2.101 Days Geometric Coefficient of Variation 28.820	—

SECONDARY outcome

Timeframe: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.

Population: PK Analysis Set includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated.

MMAE AUC was derived from the PK blood samples collected.

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=77 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
PK Parameter: MMAE AUC (Part B) Cycle 1, Dose 3 - AUC Last-MMAE	16.578 ng/mL*day Geometric Coefficient of Variation 52.121	—
PK Parameter: MMAE AUC (Part B) Cycle 1, Dose 1 - AUC Last-MMAE	8.709 ng/mL*day Geometric Coefficient of Variation 63.747	—

SECONDARY outcome

Timeframe: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.

Population: PK analysis set which includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated.

MMAE Ctrough was derived from the PK blood samples collected.

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=77 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
PK Parameter: MMAE Trough Concentration (Ctrough) (Part B)	0.230 ng/mL Geometric Coefficient of Variation 82.638	—

SECONDARY outcome

Timeframe: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.

Population: PK analysis set which includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated.

TAb Cmax was derived from the PK blood samples collected.

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=77 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
PK Parameter: Total Antibody (TAb) Cmax (Part B) Cycle 1, Dose 1	18.418 ng/mL Geometric Coefficient of Variation 28.631	—
PK Parameter: Total Antibody (TAb) Cmax (Part B) Cycle 1, Dose 3	19.955 ng/mL Geometric Coefficient of Variation 28.405	—

SECONDARY outcome

Timeframe: Samples for PK measures were collected at Cycle 1 Day 1 (predose, end of infusion, 1 hr, and 5 hr), Day 3, Day 8 (predose), Day 15 (predose, end of infusion, 1 hr, and 5 hr), Day 17, Day 22, and Cycle 2 Day 1 (predose). Approximately 4 weeks per cycle.

Population: PK analysis set which includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated.

TAb Tmax was derived from the PK blood samples collected.

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=77 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
PK Parameter: TAb Tmax (Part B) Cycle 1, Dose 1	0.041 Days Geometric Coefficient of Variation 67.072	—
PK Parameter: TAb Tmax (Part B) Cycle 1, Dose 3	0.043 Days Geometric Coefficient of Variation 67.795	—

SECONDARY outcome

Timeframe: Cycle 1 Dose 1 AUC 7: Assessed from Cycle 1 Days 1 - 8 (predose). Cycle 1 Dose 3 AUC 7: Assessed from Cycle 1 Days 15 - 22. Cycle 1 Dose 3 AUC 14: Assessed from Cycle 1 Days 15 - Cycle 2 Day 1 (predose).

Population: PK Analysis Set includes enrolled participants who received any amount of study drug and at least one PK parameter can be estimated.

TAb AUC was derived from the PK blood samples collected.

Outcome measures

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=77 Participants Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
PK Parameter: TAb Area Under Concentration-Time Curve (AUC) (Part B) Cycle 1, Dose 1 - AUC 7 Days-TAb	35.535 µg/mL*day Geometric Coefficient of Variation 24.950	—
PK Parameter: TAb Area Under Concentration-Time Curve (AUC) (Part B) Cycle 1, Dose 3 - AUC 7 Days-TAb	39.371 µg/mL*day Geometric Coefficient of Variation 29.218	—
PK Parameter: TAb Area Under Concentration-Time Curve (AUC) (Part B) Cycle 1, Dose 3 - AUC 14 Days-TAb	42.240 µg/mL*day Geometric Coefficient of Variation 29.206	—

Adverse Events

Safety Run-In 0.9 mg/kg 3Q4W

Serious events: 2 serious events

Other events: 7 other events

Deaths: 6 deaths

Safety Run-In 1.2 mg/kg 3Q4W

Serious events: 4 serious events

Other events: 8 other events

Deaths: 5 deaths

Part B Expansion

Serious events: 28 serious events

Other events: 77 other events

Deaths: 53 deaths

Serious adverse events

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=7 participants at risk Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W n=8 participants at risk Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Part B Expansion n=79 participants at risk Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Blood and lymphatic system disorders Anaemia	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	3.8% 3/79 • Number of events 4 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Cardiac disorders Angina pectoris	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Cardiac disorders Tachycardia	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	2.5% 2/79 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Ascites	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Constipation	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	37.5% 3/8 • Number of events 3 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Enteritis	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	6.3% 5/79 • Number of events 6 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Nausea	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	2.5% 2/79 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	3.8% 3/79 • Number of events 3 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Vomiting	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	2.5% 2/79 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
General disorders Fatigue	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
General disorders Pain	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
General disorders Performance status decreased	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Hepatobiliary disorders Hepatomegaly	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Infections and infestations Cellulitis	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Infections and infestations Pneumonia	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Infections and infestations Sepsis	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Infections and infestations Septic shock	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Infections and infestations Urinary tract infection	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Metabolism and nutrition disorders Decreased appetite	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Metabolism and nutrition disorders Dehydration	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	2.5% 2/79 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Psychiatric disorders Confusional state	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Renal and urinary disorders Acute kidney injury	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Renal and urinary disorders Haematuria	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Renal and urinary disorders Urinary retention	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	2.5% 2/79 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	2.5% 2/79 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Respiratory, thoracic and mediastinal disorders Pleural effusion	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	5.1% 4/79 • Number of events 4 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	2.5% 2/79 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Vascular disorders Deep vein thrombosis	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.

Other adverse events

Measure	Safety Run-In 0.9 mg/kg 3Q4W n=7 participants at risk Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Safety Run-In 1.2 mg/kg 3Q4W n=8 participants at risk Tisotumab Vedotin 1.2 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle	Part B Expansion n=79 participants at risk Tisotumab Vedotin 0.9 mg/kg by IV infusion on Days 1, 8, and 15 of every 4-week cycle
Blood and lymphatic system disorders Anaemia	57.1% 4/7 • Number of events 6 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	29.1% 23/79 • Number of events 33 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Blepharitis	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	8.9% 7/79 • Number of events 9 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Cataract nuclear	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Conjunctival haemorrhage	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Conjunctival ulcer	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Conjunctivitis allergic	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Dacryostenosis acquired	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Dry eye	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	15.2% 12/79 • Number of events 14 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Ectropion	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Entropion	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	2.5% 2/79 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Eye discharge	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	6.3% 5/79 • Number of events 8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Eye pain	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Keratitis	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	5.1% 4/79 • Number of events 9 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Lacrimation increased	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	8.9% 7/79 • Number of events 8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Punctate keratitis	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	25.0% 2/8 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	2.5% 2/79 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Symblepharon	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	5.1% 4/79 • Number of events 4 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Eye disorders Vision blurred	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	11.4% 9/79 • Number of events 10 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Abdominal distension	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	10.1% 8/79 • Number of events 9 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	37.5% 3/8 • Number of events 3 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	27.8% 22/79 • Number of events 27 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Abdominal pain upper	14.3% 1/7 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	7.6% 6/79 • Number of events 7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Constipation	28.6% 2/7 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	37.5% 3/8 • Number of events 4 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	21.5% 17/79 • Number of events 20 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Diarrhoea	57.1% 4/7 • Number of events 4 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	25.0% 2/8 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	22.8% 18/79 • Number of events 25 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Gastrooesophageal reflux disease	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	3.8% 3/79 • Number of events 3 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Nausea	28.6% 2/7 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	25.0% 2/8 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	38.0% 30/79 • Number of events 37 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Stomatitis	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	2.5% 2/79 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	19.0% 15/79 • Number of events 19 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
General disorders Asthenia	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	24.1% 19/79 • Number of events 23 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
General disorders Fatigue	28.6% 2/7 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	50.0% 4/8 • Number of events 4 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	31.6% 25/79 • Number of events 27 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
General disorders Malaise	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	2.5% 2/79 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
General disorders Oedema peripheral	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	5.1% 4/79 • Number of events 4 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
General disorders Pyrexia	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	6.3% 5/79 • Number of events 5 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	7.6% 6/79 • Number of events 16 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Infections and infestations Acute sinusitis	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Infections and infestations Conjunctivitis	28.6% 2/7 • Number of events 3 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	31.6% 25/79 • Number of events 33 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Infections and infestations Conjunctivitis viral	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Infections and infestations Device related infection	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Infections and infestations Gingivitis	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Infections and infestations Pneumonia	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Infections and infestations Pustule	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Infections and infestations Sinusitis	28.6% 2/7 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	25.0% 2/8 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	6.3% 5/79 • Number of events 6 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Infections and infestations Tooth infection	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Infections and infestations Urinary tract infection	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	6.3% 5/79 • Number of events 5 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Injury, poisoning and procedural complications Corneal abrasion	14.3% 1/7 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Injury, poisoning and procedural complications Incision site impaired healing	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Investigations Alanine aminotransferase increased	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	6.3% 5/79 • Number of events 5 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Investigations Aspartate aminotransferase increased	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	7.6% 6/79 • Number of events 6 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Investigations International normalised ratio increased	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	6.3% 5/79 • Number of events 7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Investigations Weight decreased	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	6.3% 5/79 • Number of events 5 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Metabolism and nutrition disorders Decreased appetite	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	31.6% 25/79 • Number of events 29 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Metabolism and nutrition disorders Dehydration	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	10.1% 8/79 • Number of events 8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	5.1% 4/79 • Number of events 4 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	6.3% 5/79 • Number of events 5 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	7.6% 6/79 • Number of events 7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	6.3% 5/79 • Number of events 5 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Metabolism and nutrition disorders Hypokalaemia	14.3% 1/7 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	17.7% 14/79 • Number of events 17 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Metabolism and nutrition disorders Hypomagnesaemia	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.7% 10/79 • Number of events 13 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	10.1% 8/79 • Number of events 9 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	8.9% 7/79 • Number of events 7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	8.9% 7/79 • Number of events 7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Musculoskeletal and connective tissue disorders Muscle spasms	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	2.5% 2/79 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	10.1% 8/79 • Number of events 9 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	5.1% 4/79 • Number of events 5 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Nervous system disorders Cognitive disorder	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Nervous system disorders Dizziness	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	5.1% 4/79 • Number of events 4 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Nervous system disorders Headache	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	6.3% 5/79 • Number of events 5 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Nervous system disorders Paraesthesia	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	2.5% 2/79 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Nervous system disorders Peripheral sensory neuropathy	42.9% 3/7 • Number of events 3 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	25.0% 2/8 • Number of events 3 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	22.8% 18/79 • Number of events 20 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Nervous system disorders Restless legs syndrome	28.6% 2/7 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Psychiatric disorders Depression	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	3.8% 3/79 • Number of events 3 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Psychiatric disorders Insomnia	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	3.8% 3/79 • Number of events 3 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Renal and urinary disorders Acute kidney injury	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Renal and urinary disorders Dysuria	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Renal and urinary disorders Haematuria	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	5.1% 4/79 • Number of events 6 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	6.3% 5/79 • Number of events 6 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Reproductive system and breast disorders Vulvovaginal pain	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	7.6% 6/79 • Number of events 7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Respiratory, thoracic and mediastinal disorders Dysphonia	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	11.4% 9/79 • Number of events 9 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Respiratory, thoracic and mediastinal disorders Epistaxis	57.1% 4/7 • Number of events 4 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	37.5% 3/8 • Number of events 4 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	45.6% 36/79 • Number of events 46 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Respiratory, thoracic and mediastinal disorders Nasal congestion	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	37.5% 3/8 • Number of events 3 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	11.4% 9/79 • Number of events 9 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	28.6% 2/7 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	2.5% 2/79 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Skin and subcutaneous tissue disorders Alopecia	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	25.0% 2/8 • Number of events 2 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.7% 10/79 • Number of events 10 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Skin and subcutaneous tissue disorders Dry skin	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	5.1% 4/79 • Number of events 4 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Skin and subcutaneous tissue disorders Rash erythematous	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/79 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Skin and subcutaneous tissue disorders Rash maculo-papular	14.3% 1/7 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	0.00% 0/8 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.
Vascular disorders Hot flush	0.00% 0/7 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	12.5% 1/8 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.	1.3% 1/79 • Number of events 1 • Non-serious AEs were followed up to 10.5 months. Serious AEs and All-Cause Mortality were followed up to 31.6 months. All-cause mortality includes all participants that were enrolled in the study regardless of whether or not they received treatment. Non-serious AEs and SAEs were collected and reported for patients that received treatment in their respective arms.

Additional Information

Chief Medical Officer

Seagen Inc.

Phone: (855) 473-2436

Email: medinfo@seagen.com

Results disclosure agreements

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