Trial Outcomes & Findings for CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor (NCT NCT04145349)

NCT ID: NCT04145349

Last Updated: 2025-12-08

Results Overview

PFS was defined as the time from randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause in the absence of disease progression. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). The posterior median and 98% credible interval were estimated using Bayesian analysis. Data are presented as the posterior median with 98% credible interval.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE1/PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: Randomization to Objective Progression or Death Due to Any Cause (Up To 23 Months)
• Results posted on: 2025-12-08

Participant Flow

Participant milestones

Measure	Ramucirumab + Cyclophosphamide + Vinorelbine Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 milligrams per kilogram (mg/kg) as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 milligrams per meter square (mg/m2) daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.	Cyclophosphamide + Vinorelbine Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
Overall Study STARTED	20	10
Overall Study Received at Least One Dose of Study Drug	20	10
Overall Study COMPLETED	17	8
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Ramucirumab + Cyclophosphamide + Vinorelbine Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 milligrams per kilogram (mg/kg) as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 milligrams per meter square (mg/m2) daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.	Cyclophosphamide + Vinorelbine Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
Overall Study Withdrawal by Subject	3	0
Overall Study Lost to Follow-up	0	1
Overall Study On study treatment (Ongoing)	0	1

Baseline Characteristics

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor

Baseline characteristics by cohort

Measure	Ramucirumab + Cyclophosphamide + Vinorelbine n=20 Participants Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.	Cyclophosphamide + Vinorelbine n=10 Participants Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.	Total n=30 Participants Total of all reporting groups
Age, Continuous	19.6 years STANDARD_DEVIATION 5.67 • n=37 Participants	21.4 years STANDARD_DEVIATION 5.06 • n=37 Participants	20.2 years STANDARD_DEVIATION 5.45 • n=74 Participants
Sex: Female, Male Female	5 Participants n=37 Participants	0 Participants n=37 Participants	5 Participants n=74 Participants
Sex: Female, Male Male	15 Participants n=37 Participants	10 Participants n=37 Participants	25 Participants n=74 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=37 Participants	1 Participants n=37 Participants	4 Participants n=74 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=37 Participants	8 Participants n=37 Participants	24 Participants n=74 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=37 Participants	1 Participants n=37 Participants	2 Participants n=74 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Race (NIH/OMB) Asian	2 Participants n=37 Participants	4 Participants n=37 Participants	6 Participants n=74 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Race (NIH/OMB) Black or African American	4 Participants n=37 Participants	1 Participants n=37 Participants	5 Participants n=74 Participants
Race (NIH/OMB) White	13 Participants n=37 Participants	4 Participants n=37 Participants	17 Participants n=74 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=37 Participants	1 Participants n=37 Participants	2 Participants n=74 Participants
Region of Enrollment United States	5 Participants n=37 Participants	4 Participants n=37 Participants	9 Participants n=74 Participants
Region of Enrollment Japan	1 Participants n=37 Participants	3 Participants n=37 Participants	4 Participants n=74 Participants
Region of Enrollment Italy	3 Participants n=37 Participants	1 Participants n=37 Participants	4 Participants n=74 Participants
Region of Enrollment United Kingdom	5 Participants n=37 Participants	1 Participants n=37 Participants	6 Participants n=74 Participants
Region of Enrollment Australia	1 Participants n=37 Participants	0 Participants n=37 Participants	1 Participants n=74 Participants
Region of Enrollment Germany	3 Participants n=37 Participants	0 Participants n=37 Participants	3 Participants n=74 Participants
Region of Enrollment Spain	2 Participants n=37 Participants	1 Participants n=37 Participants	3 Participants n=74 Participants

PRIMARY outcome

Timeframe: Randomization to Objective Progression or Death Due to Any Cause (Up To 23 Months)

Population: All randomized participants who received at least one dose of study drug (including the censored participants). Number of participants censored in Ramucirumab + Cyclophosphamide + Vinorelbine = 4, Cyclophosphamide + Vinorelbine = 2.

PFS was defined as the time from randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause in the absence of disease progression. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). The posterior median and 98% credible interval were estimated using Bayesian analysis. Data are presented as the posterior median with 98% credible interval.

Outcome measures

Measure	Ramucirumab + Cyclophosphamide + Vinorelbine n=20 Participants Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.	Cyclophosphamide + Vinorelbine n=10 Participants Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
Progression Free Survival (PFS)	NA Months The posterior median = 5.69, 98% credible interval (3.20 to 10.01)	NA Months The posterior median = 3.73, 98% credible interval (1.76 to 8.29)

SECONDARY outcome

Timeframe: Randomization until measured progressive disease (Up To 23 Months)

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

• The ORR was defined as the percentage of participants achieving either a CR or PR. Tumor response was assessed based on histology: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) was used for solid tumors, and Response Assessment in Neuro-Oncology criteria were used for glioblastoma.
• CR was defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) showing a reduction in the short axis to <10 mm. Tumor marker results were required to have normalized. PR was defined as a decrease of at least 30% in the sum of the diameters of target lesions, using baseline diameters as the reference.

Outcome measures

Measure	Ramucirumab + Cyclophosphamide + Vinorelbine n=20 Participants Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.	Cyclophosphamide + Vinorelbine n=10 Participants Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)	10 Percentage of participants Interval 2.7 to 24.5	10 Percentage of participants Interval 1.1 to 33.7

SECONDARY outcome

Timeframe: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 23 Months)

Population: All randomized participants who received at least one dose of study drug and who had CR or PR responses (including the censored participants). Number of participants censored in Ramucirumab + Cyclophosphamide + Vinorelbine = 0, Cyclophosphamide + Vinorelbine = 1.

DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence .Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later).

Outcome measures

Measure	Ramucirumab + Cyclophosphamide + Vinorelbine n=2 Participants Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.	Cyclophosphamide + Vinorelbine n=1 Participants Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
Duration of Response (DoR)	9.55 Months Interval 4.89 to There were not enough events to estimate the upper limit of the 80% confidence interval.	NA Months Estimation of the median and the 80% confidence interval limits (lower and upper) was not possible as the participant did not achieve the event and was censored.

SECONDARY outcome

Timeframe: Randomization until measured progressive disease (Up To 23 Months)

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

CR was defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) showing a reduction in the short axis to <10 mm.Tumor marker results were required to have normalized.

Outcome measures

Measure	Ramucirumab + Cyclophosphamide + Vinorelbine n=20 Participants Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.	Cyclophosphamide + Vinorelbine n=10 Participants Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
Complete Response (CR) : Percentage of Participants Who Achieved a CR	5.0 Percentage of participants Interval 0.5 to 18.1	0 Percentage of participants Interval 0.0 to 20.6

SECONDARY outcome

Timeframe: End of ramucirumab infusion on Day 1 of Cycle 1

Population: All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data for this outcome.

Cmax was the concentration of study drug in the blood after the dose is administered. It was measured post-dose and was summarized using descriptive statistics.

Outcome measures

Measure	Ramucirumab + Cyclophosphamide + Vinorelbine n=14 Participants Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.	Cyclophosphamide + Vinorelbine Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax)	238 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 35	—

SECONDARY outcome

Timeframe: Prior to ramucirumab infusion on - Day 15 of Cycle 1 and Day 1 of Cycles 2, 4, 7, and 10

Population: All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data for this outcome. Number analyzed refers to participants evaluable at specified time points.

Cmin was the concentration of study drug in the blood immediately before the next dose was administered. It was measured pre-dose at all visits and was summarized using descriptive statistics.

Outcome measures

Measure	Ramucirumab + Cyclophosphamide + Vinorelbine n=13 Participants Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.	Cyclophosphamide + Vinorelbine Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
PK: Minimum Serum Concentration of Ramucirumab (Cmin) Day 1 of Cycle 4	157 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 37	—
PK: Minimum Serum Concentration of Ramucirumab (Cmin) Day 1 of Cycle 7	155 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 28	—
PK: Minimum Serum Concentration of Ramucirumab (Cmin) Day 15 of Cycle 1	41.6 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 57	—
PK: Minimum Serum Concentration of Ramucirumab (Cmin) Day 1 of Cycle 2	88.7 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 47	—
PK: Minimum Serum Concentration of Ramucirumab (Cmin) Day 1 of Cycle 10	NA microgram per milliliter (µg/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there were only two participants. Individual values reported:151 µg/mL, 207 µg/mL.	—

SECONDARY outcome

Timeframe: Baseline Up to 23 months

Population: All randomized participants who received at least one dose of study drug and had at least one non-missing baseline, post baseline ADA value.

A TE-ADA evaluable participant is considered TE-ADA positive if they have at least one post-baseline ADA titer that is a 4-fold or greater increase from their baseline titer (treatment-boosted); alternatively, if the baseline ADA result is Not Present, the participant is considered TE-ADA positive if there is at least one post-baseline ADA result that is Present with a titer greater than or equal to 1:20 (treatment-induced).

Outcome measures

Measure	Ramucirumab + Cyclophosphamide + Vinorelbine n=13 Participants Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.	Cyclophosphamide + Vinorelbine n=5 Participants Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA)	0 Participants	0 Participants

Adverse Events

Ramucirumab + Cyclophosphamide + Vinorelbine

Serious events: 6 serious events

Other events: 20 other events

Deaths: 12 deaths

Cyclophosphamide + Vinorelbine

Serious events: 3 serious events

Other events: 10 other events

Deaths: 7 deaths

Serious adverse events

Measure	Ramucirumab + Cyclophosphamide + Vinorelbine n=20 participants at risk Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.	Cyclophosphamide + Vinorelbine n=10 participants at risk Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
Blood and lymphatic system disorders Febrile neutropenia	10.0% 2/20 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Ascites	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Nausea	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Small intestinal obstruction	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Chest pain	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pyrexia	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Bacteraemia	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cellulitis	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cystitis	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Device related infection	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Influenza	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Viral diarrhoea	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Post procedural haemorrhage	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Syncope	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Acute kidney injury	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Other adverse events

Measure	Ramucirumab + Cyclophosphamide + Vinorelbine n=20 participants at risk Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.	Cyclophosphamide + Vinorelbine n=10 participants at risk Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
Blood and lymphatic system disorders Anaemia	40.0% 8/20 • Number of events 13 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 2/10 • Number of events 13 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Febrile neutropenia	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Leukopenia	10.0% 2/20 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Lymphopenia	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Neutropenia	55.0% 11/20 • Number of events 28 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Blood and lymphatic system disorders Thrombocytopenia	15.0% 3/20 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Angina pectoris	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Sinus tachycardia	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Cardiac disorders Tachycardia	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Endocrine disorders Hypothyroidism	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Eye swelling	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Eye disorders Ocular hyperaemia	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal distension	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	30.0% 3/10 • Number of events 4 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal pain	55.0% 11/20 • Number of events 18 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 2/10 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Anorectal discomfort	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Ascites	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Constipation	35.0% 7/20 • Number of events 7 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	30.0% 3/10 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	35.0% 7/20 • Number of events 12 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dry mouth	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Dyspepsia	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Eructation	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Flatulence	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gastritis	10.0% 2/20 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gingival bleeding	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Gingival pain	5.0% 1/20 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Haemorrhoids	5.0% 1/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Nausea	20.0% 4/20 • Number of events 6 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	30.0% 3/10 • Number of events 7 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Stomatitis	15.0% 3/20 • Number of events 4 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Vomiting	30.0% 6/20 • Number of events 11 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	40.0% 4/10 • Number of events 4 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Asthenia	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 2/10 • Number of events 4 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Catheter site rash	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Chills	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Early satiety	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Fatigue	25.0% 5/20 • Number of events 6 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 2/10 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Impaired healing	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Localised oedema	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Malaise	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Mucosal inflammation	20.0% 4/20 • Number of events 4 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pain	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pyrexia	25.0% 5/20 • Number of events 7 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	40.0% 4/10 • Number of events 7 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Thirst	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Anaphylactic reaction	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Seasonal allergy	5.0% 1/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Type iv hypersensitivity reaction	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cellulitis	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Covid-19	15.0% 3/20 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Cystitis	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Ear lobe infection	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Gingivitis	5.0% 1/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Klebsiella infection	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Nasopharyngitis	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Oral herpes	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Skin infection	5.0% 1/20 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Wound infection	5.0% 1/20 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Infusion related reaction	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Limb injury	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Wound complication	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Activated partial thromboplastin time prolonged	15.0% 3/20 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Alanine aminotransferase increased	50.0% 10/20 • Number of events 15 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 2/10 • Number of events 7 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Anion gap decreased	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Aspartate aminotransferase increased	35.0% 7/20 • Number of events 11 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 2/10 • Number of events 7 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood alkaline phosphatase increased	20.0% 4/20 • Number of events 6 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood bilirubin increased	5.0% 1/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood chloride decreased	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood creatine increased	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood creatinine increased	15.0% 3/20 • Number of events 11 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood lactate dehydrogenase increased	5.0% 1/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood thyroid stimulating hormone increased	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Blood urea increased	10.0% 2/20 • Number of events 6 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Gamma-glutamyltransferase increased	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Glomerular filtration rate decreased	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Haemoglobin increased	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations International normalised ratio increased	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Lymphocyte count decreased	25.0% 5/20 • Number of events 7 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	30.0% 3/10 • Number of events 9 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Neutrophil count decreased	50.0% 10/20 • Number of events 33 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	50.0% 5/10 • Number of events 22 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Platelet count decreased	15.0% 3/20 • Number of events 14 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Weight decreased	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 2/10 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Weight increased	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations White blood cell count decreased	55.0% 11/20 • Number of events 39 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	60.0% 6/10 • Number of events 26 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Decreased appetite	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	30.0% 3/10 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Dehydration	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypercalcaemia	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperkalaemia	10.0% 2/20 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypermagnesaemia	5.0% 1/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypernatraemia	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyperphosphataemia	10.0% 2/20 • Number of events 7 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 2/10 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypertriglyceridaemia	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypoalbuminaemia	15.0% 3/20 • Number of events 7 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypocalcaemia	15.0% 3/20 • Number of events 12 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypoglycaemia	10.0% 2/20 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 2/10 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypomagnesaemia	5.0% 1/20 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hyponatraemia	25.0% 5/20 • Number of events 7 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 2/10 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	35.0% 7/20 • Number of events 7 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 2/10 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Muscular weakness	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 1/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Cerebrovascular accident	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Dizziness	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Dysgeusia	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Headache	50.0% 10/20 • Number of events 17 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Neuropathy peripheral	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Nervous system disorders Peripheral sensory neuropathy	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Product Issues Device dislocation	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Confusional state	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Psychiatric disorders Insomnia	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Dysuria	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 2/10 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Haematuria	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Micturition urgency	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Pollakiuria	5.0% 1/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Renal and urinary disorders Proteinuria	45.0% 9/20 • Number of events 14 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Reproductive system and breast disorders Vaginal discharge	20.0% 1/5 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	— 0/0 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	30.0% 6/20 • Number of events 6 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Eczema	10.0% 2/20 • Number of events 5 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Epistaxis	40.0% 8/20 • Number of events 11 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	20.0% 2/10 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Dry skin	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Petechiae	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Rash	10.0% 2/20 • Number of events 2 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Hypertension	15.0% 3/20 • Number of events 3 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Phlebitis	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Superficial vein thrombosis	5.0% 1/20 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/10 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Vascular disorders Thrombosis	0.00% 0/20 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	10.0% 1/10 • Number of events 1 • Baseline Up to 23 months * All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. * Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

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

Restriction type: GT60