Trial Outcomes & Findings for A Trial of Dalotuzumab in Combination With Irinotecan Versus Cetuximab and Irinotecan for Participants With Metastatic Rectal Cancers (mRC) (MK-0646-025) (NCT NCT01609231)

NCT ID: NCT01609231

Last Updated: 2020-05-04

Results Overview

PFS is a measure of the time from randomization to the time of first documented disease progression (assessed by an independent Radiology Review Committee \[iRRC\]) or participant death, whichever occurs first.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 11 participants
• Primary outcome timeframe: From randomization (Cycle 1, Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to 3 years)
• Results posted on: 2020-05-04

Participant Flow

The trial was halted prematurely for business reasons.

Participant milestones

Measure	Dalotuzumab + Irinotecan Participants received irinotecan intravenously (IV), 180 mg/m\^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly, during ≥1 42-day treatment cycle(s).	Cetuximab + Irinotecan Participants received cetuximab IV, initial dose of 400 mg/m\^2 and then 250 mg/m\^2 IV weekly + irinotecan IV, 180 mg/m\^2 once every two weeks, during ≥1 42-day treatment cycle(s).
Overall Study STARTED	6	5
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Dalotuzumab + Irinotecan Participants received irinotecan intravenously (IV), 180 mg/m\^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly, during ≥1 42-day treatment cycle(s).	Cetuximab + Irinotecan Participants received cetuximab IV, initial dose of 400 mg/m\^2 and then 250 mg/m\^2 IV weekly + irinotecan IV, 180 mg/m\^2 once every two weeks, during ≥1 42-day treatment cycle(s).
Overall Study Adverse Event	1	3
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

A Trial of Dalotuzumab in Combination With Irinotecan Versus Cetuximab and Irinotecan for Participants With Metastatic Rectal Cancers (mRC) (MK-0646-025)

Baseline characteristics by cohort

Measure	Dalotuzumab + Irinotecan n=6 Participants Participants received irinotecan IV, 180 mg/m\^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly, during ≥1 42-day treatment cycle(s).	Cetuximab + Irinotecan n=5 Participants Participants received cetuximab IV, initial dose of 400 mg/m\^2 and then 250 mg/m\^2 IV weekly + irinotecan IV, 180 mg/m\^2 once every two weeks, during ≥1 42-day treatment cycle(s).	Total n=11 Participants Total of all reporting groups
Age, Continuous	57.2 years STANDARD_DEVIATION 13.8 • n=5 Participants	64.6 years STANDARD_DEVIATION 9.9 • n=7 Participants	60.5 years STANDARD_DEVIATION 12.3 • n=5 Participants
Age, Customized Adults (18-64 years)	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Customized From 65-84 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization (Cycle 1, Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to 3 years)

Population: Due to low enrollment and early termination of study, insufficient data were collected for this endpoint, and no endpoint data were assessed by the iRRC.

PFS is a measure of the time from randomization to the time of first documented disease progression (assessed by an independent Radiology Review Committee [iRRC]) or participant death, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization (Cycle 1, Day 1) to the first documented disease progression or death due to any cause, whichever occurs first (up to 3 years)

Population: Due to low enrollment and early termination of study, insufficient data were collected for this endpoint, and no endpoint data were assessed for RECIST 1.1 criteria.

ORR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) during the course of the study using enhanced Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Confirmation of response was not required.

Outcome measures

Outcome data not reported

Adverse Events

Dalotuzumab + Irinotecan

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Cetuximab + Irinotecan

Serious events: 4 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Measure	Dalotuzumab + Irinotecan n=6 participants at risk Participants received irinotecan IV, 180 mg/m\^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly, during ≥1 42-day treatment cycle(s).	Cetuximab + Irinotecan n=5 participants at risk Participants received cetuximab IV, initial dose of 400 mg/m\^2 and then 250 mg/m\^2 IV weekly + irinotecan IV, 180 mg/m\^2 once every two weeks, during ≥1 42-day treatment cycle(s).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Ileus	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
General disorders Disease progression	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Infections and infestations Cellulitis	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Infections and infestations Pneumonia	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Infections and infestations Septic shock	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.

Other adverse events

Measure	Dalotuzumab + Irinotecan n=6 participants at risk Participants received irinotecan IV, 180 mg/m\^2 once every two weeks + dalotuzumab IV, 10 mg/kg once weekly, during ≥1 42-day treatment cycle(s).	Cetuximab + Irinotecan n=5 participants at risk Participants received cetuximab IV, initial dose of 400 mg/m\^2 and then 250 mg/m\^2 IV weekly + irinotecan IV, 180 mg/m\^2 once every two weeks, during ≥1 42-day treatment cycle(s).
Blood and lymphatic system disorders Anaemia	33.3% 2/6 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	40.0% 2/5 • Number of events 3 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Blood and lymphatic system disorders Neutropenia	16.7% 1/6 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Ear and labyrinth disorders Ear discomfort	16.7% 1/6 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Ear and labyrinth disorders Vertigo	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Eye disorders Blepharitis	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Eye disorders Conjunctivitis allergic	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Eye disorders Eye pruritus	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Abdominal discomfort	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Abdominal pain	50.0% 3/6 • Number of events 4 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	40.0% 2/5 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Abdominal pain upper	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Cheilitis	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Constipation	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	60.0% 3/5 • Number of events 4 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Diarrhoea	100.0% 6/6 • Number of events 23 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	80.0% 4/5 • Number of events 18 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Dry mouth	16.7% 1/6 • Number of events 6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	40.0% 2/5 • Number of events 3 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Frequent bowel movements	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Gingival oedema	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Haematochezia	16.7% 1/6 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Nausea	50.0% 3/6 • Number of events 7 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	80.0% 4/5 • Number of events 9 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Oral pain	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Stomatitis	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	60.0% 3/5 • Number of events 3 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Toothache	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Gastrointestinal disorders Vomiting	50.0% 3/6 • Number of events 6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	40.0% 2/5 • Number of events 5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
General disorders Asthenia	33.3% 2/6 • Number of events 6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 4 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
General disorders Catheter site pain	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
General disorders Fatigue	16.7% 1/6 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	40.0% 2/5 • Number of events 3 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
General disorders Mucosal inflammation	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	40.0% 2/5 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
General disorders Oedema peripheral	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
General disorders Pain	16.7% 1/6 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
General disorders Pyrexia	33.3% 2/6 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Infections and infestations Bacteriuria	16.7% 1/6 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Infections and infestations Candida infection	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Infections and infestations Cellulitis	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Infections and infestations Fungal skin infection	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Infections and infestations Gingival abscess	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Infections and infestations Nasopharyngitis	33.3% 2/6 • Number of events 3 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Infections and infestations Paronychia	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 3 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Infections and infestations Rhinitis	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Infections and infestations Skin infection	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Infections and infestations Urinary tract infection	16.7% 1/6 • Number of events 3 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Investigations Haemoglobin decreased	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Investigations Neutrophil count decreased	33.3% 2/6 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 3 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Investigations Platelet count decreased	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Investigations Protein urine present	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Investigations Weight decreased	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Metabolism and nutrition disorders Decreased appetite	66.7% 4/6 • Number of events 16 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	80.0% 4/5 • Number of events 5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Metabolism and nutrition disorders Hyperglycaemia	33.3% 2/6 • Number of events 3 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Musculoskeletal and connective tissue disorders Back pain	50.0% 3/6 • Number of events 4 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Musculoskeletal and connective tissue disorders Bone erosion	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Musculoskeletal and connective tissue disorders Muscle spasms	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Musculoskeletal and connective tissue disorders Muscular weakness	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 3 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	16.7% 1/6 • Number of events 3 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • Number of events 4 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Nervous system disorders Circadian rhythm sleep disorder	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Nervous system disorders Dizziness	16.7% 1/6 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Nervous system disorders Dysgeusia	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Nervous system disorders Headache	16.7% 1/6 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Nervous system disorders Neuropathy peripheral	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	40.0% 2/5 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Psychiatric disorders Insomnia	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Renal and urinary disorders Dysuria	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	40.0% 2/5 • Number of events 3 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Renal and urinary disorders Polyuria	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Renal and urinary disorders Renal failure acute	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 2/6 • Number of events 5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	50.0% 3/6 • Number of events 5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	40.0% 2/5 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Laryngeal pain	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Productive cough	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	16.7% 1/6 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Throat irritation	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Skin and subcutaneous tissue disorders Acne	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Skin and subcutaneous tissue disorders Alopecia	33.3% 2/6 • Number of events 3 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	40.0% 2/5 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	40.0% 2/5 • Number of events 3 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	40.0% 2/5 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	80.0% 4/5 • Number of events 6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Skin and subcutaneous tissue disorders Skin fissures	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	60.0% 3/5 • Number of events 6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/6 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	20.0% 1/5 • Number of events 2 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Skin and subcutaneous tissue disorders Skin mass	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.
Vascular disorders Haematoma	16.7% 1/6 • Number of events 1 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.	0.00% 0/5 • Up to approximately 553 days An adverse event (AE) is defined as any untoward medical occurrence in a participants administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All randomized participants who received ≥1 dose of study therapy are included in the safety analysis.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
• Publication restrictions are in place

Restriction type: OTHER