Trial Outcomes & Findings for Study of SCH 900776 (MK-8776) With and Without Cytarabine in Participants With Acute Leukemias (P05247) (NCT NCT00907517)

NCT ID: NCT00907517

Last Updated: 2018-08-27

Results Overview

Toxicity was assessed according to the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0). DLTs in Cycle 1 consisted of any of the following: 1) Selected Grade 4 drug-related nonhematologic toxicities, 2) Selected Grade 3 drug-related nonhematologic toxicities that do not resolve to ≤ Grade 2 within 48 hours: Neurotoxicity of any duration, Nephrotoxicity of any duration, QT interval corrected by Fridericia (QTcF) prolongation of any duration, 3) Inability to administer Day 10 cytarabine therapy due to ongoing, uncontrolled serious or life-threatening toxicity. The number of participants who experienced a DLT during Cycle 1 is summarized.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: Throughout Cycle 1 (Up to 6 weeks)
• Results posted on: 2018-08-27

Participant Flow

Only one combination treatment cycle of approximately 4 to 6 weeks duration was anticipated, but participants may have received additional cycles of treatment if clinically indicated after discussion between the Investigator and the Sponsor.

Participant milestones

Measure	MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 Participants received MK-8776 10 mg/m\^2 intravenously (IV) on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour continuous intravenous infusion (CIV) on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 Participants received MK-8776 20 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 Participants received MK-8776 40 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 Participants received MK-8776 56 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 140 mg + Cytarabine 2 g/m^2 Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Overall Study STARTED	3	3	6	6	6
Overall Study COMPLETED	0	0	2	2	1
Overall Study NOT COMPLETED	3	3	4	4	5

Reasons for withdrawal

Measure	MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 Participants received MK-8776 10 mg/m\^2 intravenously (IV) on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour continuous intravenous infusion (CIV) on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 Participants received MK-8776 20 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 Participants received MK-8776 40 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 Participants received MK-8776 56 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 140 mg + Cytarabine 2 g/m^2 Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Overall Study Progressive Disease	3	3	4	4	4
Overall Study Symptomatic Deterioration	0	0	0	0	1

Baseline Characteristics

Study of SCH 900776 (MK-8776) With and Without Cytarabine in Participants With Acute Leukemias (P05247)

Baseline characteristics by cohort

Measure	MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 n=3 Participants Participants received MK-8776 10 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 n=3 Participants Participants received MK-8776 20 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 n=6 Participants Participants received MK-8776 40 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 n=6 Participants Participants received MK-8776 56 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 140 mg + Cytarabine 2 g/m^2 n=6 Participants Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	Total n=24 Participants Total of all reporting groups
Age, Continuous	59.3 Years STANDARD_DEVIATION 9.1 • n=5 Participants	55.7 Years STANDARD_DEVIATION 1.5 • n=7 Participants	44.2 Years STANDARD_DEVIATION 14.2 • n=5 Participants	57.5 Years STANDARD_DEVIATION 18.3 • n=4 Participants	56.3 Years STANDARD_DEVIATION 13.5 • n=21 Participants	53.9 Years STANDARD_DEVIATION 14.0 • n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	13 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	11 Participants n=8 Participants

PRIMARY outcome

Timeframe: Throughout Cycle 1 (Up to 6 weeks)

Population: The population consisted of all participants who received at least one dose of study treatment.

Toxicity was assessed according to the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0). DLTs in Cycle 1 consisted of any of the following: 1) Selected Grade 4 drug-related nonhematologic toxicities, 2) Selected Grade 3 drug-related nonhematologic toxicities that do not resolve to ≤ Grade 2 within 48 hours: Neurotoxicity of any duration, Nephrotoxicity of any duration, QT interval corrected by Fridericia (QTcF) prolongation of any duration, 3) Inability to administer Day 10 cytarabine therapy due to ongoing, uncontrolled serious or life-threatening toxicity. The number of participants who experienced a DLT during Cycle 1 is summarized.

Outcome measures

Measure	MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 n=3 Participants Participants received MK-8776 10 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 n=3 Participants Participants received MK-8776 20 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 n=6 Participants Participants received MK-8776 40 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 n=6 Participants Participants received MK-8776 56 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 140 mg + Cytarabine 2 g/m^2 n=6 Participants Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants

PRIMARY outcome

Timeframe: Up to 45 days after last dose of study treatment (Up to 180 days)

Population: The population consisted of all participants who received at least one dose of study treatment.

An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment. The number of participants who experienced an AE is summarized.

Outcome measures

Measure	MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 n=3 Participants Participants received MK-8776 10 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 n=3 Participants Participants received MK-8776 20 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 n=6 Participants Participants received MK-8776 40 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 n=6 Participants Participants received MK-8776 56 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 140 mg + Cytarabine 2 g/m^2 n=6 Participants Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Number of Participants Who Experienced an Adverse Event (AE)	3 Participants	3 Participants	6 Participants	6 Participants	6 Participants

PRIMARY outcome

Timeframe: Up to 135 days

Population: The population consisted of all participants who received at least one dose of study treatment.

An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to this study treatment. The number of participants who discontinued study treatment due to an AE is summarized.

Outcome measures

Measure	MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 n=3 Participants Participants received MK-8776 10 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 n=3 Participants Participants received MK-8776 20 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 n=6 Participants Participants received MK-8776 40 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 n=6 Participants Participants received MK-8776 56 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 140 mg + Cytarabine 2 g/m^2 n=6 Participants Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Number of Participants Who Discontinued Study Treatment Due to an AE	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

MK-8776 140 mg + Cytarabine 2 g/m^2

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 n=3 participants at risk Participants received MK-8776 10 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 n=3 participants at risk Participants received MK-8776 20 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 n=6 participants at risk Participants received MK-8776 40 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 n=6 participants at risk Participants received MK-8776 56 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 140 mg + Cytarabine 2 g/m^2 n=6 participants at risk Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders GASTRITIS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders NAUSEA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders VOMITING	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Infections and infestations FUNGAL INFECTION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Infections and infestations PNEUMONIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Infections and infestations PNEUMONIA FUNGAL	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Nervous system disorders HEADACHE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Renal and urinary disorders RENAL FAILURE ACUTE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Vascular disorders HYPERTENSION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.

Other adverse events

Measure	MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2 n=3 participants at risk Participants received MK-8776 10 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2 n=3 participants at risk Participants received MK-8776 20 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2 n=6 participants at risk Participants received MK-8776 40 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2 n=6 participants at risk Participants received MK-8776 56 mg/m\^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).	MK-8776 140 mg + Cytarabine 2 g/m^2 n=6 participants at risk Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m\^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
Infections and infestations TOOTH ABSCESS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications EYE INJURY	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications PERIORBITAL HAEMATOMA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications RIB FRACTURE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders DISSEMINATED INTRAVASCULAR COAGULATION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	66.7% 2/3 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	83.3% 5/6 • Number of events 6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	50.0% 3/6 • Number of events 5 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	83.3% 5/6 • Number of events 7 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders LEUKOPENIA	33.3% 1/3 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders LYMPHOPENIA	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders NEUTROPENIA	33.3% 1/3 • Number of events 4 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 4 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders SPLENOMEGALY	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders THROMBOCYTOPENIA	33.3% 1/3 • Number of events 16 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Cardiac disorders CARDIOMEGALY	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Cardiac disorders EXTRASYSTOLES	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Cardiac disorders PERICARDIAL EFFUSION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	66.7% 2/3 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Cardiac disorders TRICUSPID VALVE INCOMPETENCE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Ear and labyrinth disorders EAR PAIN	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Ear and labyrinth disorders HYPOACUSIS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Endocrine disorders DIABETES INSIPIDUS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Eye disorders CONJUNCTIVAL HAEMORRHAGE	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Eye disorders CONJUNCTIVITIS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Eye disorders DRY EYE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Eye disorders PERIORBITAL OEDEMA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Eye disorders VISUAL IMPAIRMENT	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders ABDOMINAL TENDERNESS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders CONSTIPATION	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders DIARRHOEA	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	66.7% 4/6 • Number of events 4 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	66.7% 4/6 • Number of events 6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders DRY MOUTH	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders DYSPEPSIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders EPIGASTRIC DISCOMFORT	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders GINGIVAL BLEEDING	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders HAEMORRHOIDS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders MELAENA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders MOUTH HAEMORRHAGE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders NAUSEA	33.3% 1/3 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	66.7% 4/6 • Number of events 7 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	83.3% 5/6 • Number of events 5 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	83.3% 5/6 • Number of events 6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders OESOPHAGEAL ULCER	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders PROCTALGIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders SALIVARY HYPERSECRETION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders STOMATITIS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Gastrointestinal disorders VOMITING	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	50.0% 3/6 • Number of events 7 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	66.7% 4/6 • Number of events 4 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
General disorders CATHETER SITE ERYTHEMA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
General disorders CHILLS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
General disorders FATIGUE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	50.0% 3/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
General disorders MALAISE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
General disorders MUCOSAL INFLAMMATION	66.7% 2/3 • Number of events 12 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	66.7% 4/6 • Number of events 5 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
General disorders NODULE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
General disorders OEDEMA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
General disorders OEDEMA PERIPHERAL	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	66.7% 2/3 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
General disorders PAIN	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
General disorders PYREXIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 9 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Hepatobiliary disorders HYPERBILIRUBINAEMIA	66.7% 2/3 • Number of events 8 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 12 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Infections and infestations BACTERAEMIA	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Infections and infestations CANDIDIASIS	66.7% 2/3 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Infections and infestations CELLULITIS ORBITAL	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Infections and infestations FUNGAEMIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Infections and infestations MASTOIDITIS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Infections and infestations PNEUMONIA	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	66.7% 2/3 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Infections and infestations PNEUMONIA FUNGAL	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Infections and infestations SEPSIS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Infections and infestations SINUSITIS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Infections and infestations STAPHYLOCOCCAL INFECTION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Infections and infestations TINEA INFECTION	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications TRANSFUSION REACTION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	50.0% 3/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Investigations ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Investigations ALANINE AMINOTRANSFERASE INCREASED	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	50.0% 3/6 • Number of events 10 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 7 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	50.0% 3/6 • Number of events 8 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 9 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	33.3% 1/3 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	66.7% 4/6 • Number of events 5 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Investigations BLOOD CREATININE DECREASED	33.3% 1/3 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Investigations BLOOD CREATININE INCREASED	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	50.0% 3/6 • Number of events 5 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Investigations CARDIAC MURMUR	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Investigations EJECTION FRACTION DECREASED	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Investigations ELECTROCARDIOGRAM QT PROLONGED	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Investigations FUNGAL TEST POSITIVE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Investigations TROPONIN INCREASED	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Investigations WEIGHT DECREASED	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Investigations WHITE BLOOD CELL COUNT INCREASED	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders FLUID OVERLOAD	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders FLUID RETENTION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders HYPERALBUMINAEMIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders HYPERCHOLESTEROLAEMIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders HYPERGLYCAEMIA	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders HYPERTRIGLYCERIDAEMIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders HYPOALBUMINAEMIA	66.7% 2/3 • Number of events 5 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders HYPOCALCAEMIA	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders HYPOKALAEMIA	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	50.0% 3/6 • Number of events 4 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 7 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 4 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 4 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders HYPOPHAGIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	33.3% 1/3 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders TUMOUR LYSIS SYNDROME	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders ARTHRALGIA	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders BACK PAIN	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders BONE PAIN	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders TENDONITIS	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Nervous system disorders DIZZINESS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Nervous system disorders DYSGEUSIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Nervous system disorders HEADACHE	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	50.0% 3/6 • Number of events 5 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Nervous system disorders MIGRAINE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Nervous system disorders NEUROPATHY PERIPHERAL	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Psychiatric disorders ABNORMAL DREAMS	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Psychiatric disorders AGITATION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Psychiatric disorders ANXIETY	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Psychiatric disorders DELIRIUM	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Psychiatric disorders DEPRESSION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Psychiatric disorders HALLUCINATION, AUDITORY	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Psychiatric disorders INSOMNIA	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	50.0% 3/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Renal and urinary disorders BLADDER PAIN	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Renal and urinary disorders CYSTITIS HAEMORRHAGIC	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Renal and urinary disorders DYSURIA	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Renal and urinary disorders HAEMATURIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Renal and urinary disorders HYDRONEPHROSIS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Renal and urinary disorders INCONTINENCE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Renal and urinary disorders NEPHROGENIC DIABETES INSIPIDUS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Renal and urinary disorders NEUROGENIC BLADDER	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Renal and urinary disorders RENAL FAILURE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Reproductive system and breast disorders BREAST CYST	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Reproductive system and breast disorders UTERINE HAEMORRHAGE	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders NASAL DRYNESS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders PARANASAL SINUS HYPERSECRETION	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders PLEURITIC PAIN	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders THROAT IRRITATION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders UPPER-AIRWAY COUGH SYNDROME	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders WHEEZING	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders ALOPECIA	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders DRUG ERUPTION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders PRURITUS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 2/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders RASH	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	50.0% 3/6 • Number of events 3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders RASH GENERALISED	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders RASH PRURITIC	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders SKIN EXFOLIATION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders SKIN MASS	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	33.3% 1/3 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Vascular disorders HYPERTENSION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	83.3% 5/6 • Number of events 10 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/6 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.
Vascular disorders HYPOTENSION	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	0.00% 0/3 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 2 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • Up to 45 days after last dose of study treatment (Up to 180 days) The population consisted of all participants who received at least one dose of study treatment.

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 investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
• Publication restrictions are in place

Restriction type: OTHER