Trial Outcomes & Findings for Tagraxofusp (SL-401) in Participants With Chronic Myelomonocytic Leukemia (CMML) and Myelofibrosis (MF) (NCT NCT02268253)

Last Updated: 2025-01-06

Results Overview

During Stage 1, DLT was defined as any of the following occurring during the first cycle of therapy: any treatment-emergent Grade 4 transaminase or creatine phosphokinase (CPK) elevation (confirmed within 24 hours of initial identification), regardless of duration or relationship to SL-401; any Grade ≥3 non-hematologic toxicity (unrelated to underlying MPN), with the exception of Grade 3 laboratory toxicities that resolve to Grade ≤1 or baseline ≤28 days after the last infusion of SL-401, or the following Grade 3 toxicities if they resolve to Grade ≤1 or baseline ≤21 days after the last infusion of SL-401, arthralgia, myalgia, fever responding to treatment, nausea and/or vomiting (excluding cases that require tube feeding, total parenteral nutrition, or hospitalization) or diarrhea associated with suboptimal prophylaxis or treatment; Grade 4 neutropenia or Grade 4 thrombocytopenia with a duration (at Grade 4) of ≥28 days.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

82 participants

Primary outcome timeframe

21 days of Cycle 1 (21 days/cycle)

Results posted on

2025-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Level 1 - Tagraxofusp - 7 Micrograms/Kilogram (µg/kg)/Day - Chronic Myelomonocytic Leukemia Tagraxofusp was administered as a 15-minute intravenous (IV) infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Advanced Systemic Mastocytosis Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
Stage 1 STARTED	1	2	2	2	1	1	0
Stage 1 Received At Least 1 Dose of Study Drug	1	2	2	2	1	1	0
Stage 1 Treatment Naïve (Modified Intent-to-Treat)	1	1	0	0	0	0	0
Stage 1 Relapsed/Refractory (Modified Intent-to-Treat)	0	1	2	2	0	1	0
Stage 1 COMPLETED	0	0	0	0	0	0	0
Stage 1 NOT COMPLETED	1	2	2	2	1	1	0
Stage 2 STARTED	0	0	24	0	0	35	1
Stage 2 Received At Least 1 Dose of Study Drug	0	0	24	0	0	35	1
Stage 2 Treatment Naïve (Modified Intent-to-Treat)	0	0	8	0	0	5	0
Stage 2 Relapsed/Refractory (Modified Intent-to-Treat)	0	0	15	0	0	24	0
Stage 2 COMPLETED	0	0	0	0	0	0	0
Stage 2 NOT COMPLETED	0	0	24	0	0	35	1
Stage 3A STARTED	0	0	13	0	0	0	0
Stage 3A Received At Least 1 Dose of Study Drug	0	0	13	0	0	0	0
Stage 3A Treatment Naïve (Modified Intent-to-Treat)	0	0	7	0	0	0	0
Stage 3A Relapsed/Refractory (Modified Intent-to-Treat)	0	0	5	0	0	0	0
Stage 3A COMPLETED	0	0	0	0	0	0	0
Stage 3A NOT COMPLETED	0	0	13	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Level 1 - Tagraxofusp - 7 Micrograms/Kilogram (µg/kg)/Day - Chronic Myelomonocytic Leukemia Tagraxofusp was administered as a 15-minute intravenous (IV) infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Advanced Systemic Mastocytosis Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
Stage 1 Withdrawal by Subject	1	0	0	0	0	0	0
Stage 1 Death	0	2	2	2	1	1	0
Stage 2 Disease Recurrence/ Progression	0	0	1	0	0	0	0
Stage 2 Withdrawal by Subject	0	0	2	0	0	2	0
Stage 2 Completion of 7 or More Cycles of Treatment	0	0	2	0	0	7	0
Stage 2 Death	0	0	19	0	0	20	1
Stage 2 Lost to Follow-up	0	0	0	0	0	4	0
Stage 2 Transferred to Hospice	0	0	0	0	0	2	0
Stage 3A Disease Recurrence/ Progression	0	0	1	0	0	0	0
Stage 3A Withdrawal by Subject	0	0	2	0	0	0	0
Stage 3A Physician Decision	0	0	2	0	0	0	0
Stage 3A Study Terminated by Sponsor	0	0	2	0	0	0	0
Stage 3A Lost to Follow-up	0	0	1	0	0	0	0
Stage 3A Death	0	0	5	0	0	0	0

Baseline Characteristics

Tagraxofusp (SL-401) in Participants With Chronic Myelomonocytic Leukemia (CMML) and Myelofibrosis (MF)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1 -Tagraxofusp - 7 µg/kg/Day - Chronic Myelomonocytic Leukemia n=1 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia n=2 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia n=39 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis n=2 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis n=1 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis n=36 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Advanced Systemic Mastocytosis n=1 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Total n=82 Participants Total of all reporting groups
Age, Continuous	42.0 years STANDARD_DEVIATION NA • n=5 Participants	66.0 years STANDARD_DEVIATION 4.24 • n=7 Participants	69.1 years STANDARD_DEVIATION 8.88 • n=5 Participants	65.5 years STANDARD_DEVIATION 4.95 • n=4 Participants	81.0 years STANDARD_DEVIATION NA • n=21 Participants	70.4 years STANDARD_DEVIATION 7.97 • n=8 Participants	63 years STANDARD_DEVIATION NA • n=8 Participants	69.3 years STANDARD_DEVIATION 8.81 • n=24 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	16 Participants n=8 Participants	0 Participants n=8 Participants	29 Participants n=24 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	29 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	20 Participants n=8 Participants	1 Participants n=8 Participants	53 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants	0 Participants n=8 Participants	10 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=8 Participants	5 Participants n=24 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	32 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	25 Participants n=8 Participants	1 Participants n=8 Participants	62 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=8 Participants	4 Participants n=24 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0	0 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=8 Participants	9 Participants n=24 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1	1 Participants n=5 Participants	2 Participants n=7 Participants	29 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	23 Participants n=8 Participants	1 Participants n=8 Participants	57 Participants n=24 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 2	0 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	10 Participants n=8 Participants	0 Participants n=8 Participants	16 Participants n=24 Participants

PRIMARY outcome

Timeframe: 21 days of Cycle 1 (21 days/cycle)

Population: Safety Population: All participants who received at least 1 dose of study drug during Stage 1 only. 'Dose Level 3 - Tagraxofusp - 12 μg/kg/Day - Advanced Systemic Mastocytosis' arm enrolled during Stage 2. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure in Stage 1 only.

Outcome measures

Outcome measures
Measure	Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Chronic Myelomonocytic Leukemia n=1 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia n=2 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia n=2 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis n=2 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis n=1 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis n=1 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
Number of Participants With Dose-limiting Toxicities (DLTs)	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: 1145 days

Population: Modified Intent-to-Treat (mITT): Any participant who received at least 1 dose of study intervention and was evaluable for efficacy assessment. Presentation of reporting groups based upon shared criteria used for response assessment and prior treatment history (previously untreated \[treatment naive\]; previously treated \[relapsed/refractory\]). Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.

ORR was defined as the percentage of participants (responders) who achieved disease-specific complete response (CR) or partial response (PR) after treatment. For response assessment of myelofibrosis during both Stage 1 and Stage 2, the International Working Group-Myeloproliferative Neoplasms Research and Treatment and European LeukemiaNet (IWG-MRT/ELN 2013) criteria were used. For chronic myelomonocytic leukemia, during both Stage 1 and Stage 2, the International Working Group 2006 response criteria for myelodysplastic syndromes (IWG MDS 2006) were used for response assessment while the Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) 2015 criteria were used for response assessment during Stage 3A.

Outcome measures

Outcome measures
Measure	Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Chronic Myelomonocytic Leukemia n=5 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia n=25 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia n=8 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis n=17 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis n=7 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis n=5 Participants Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
Objective Response Rate (ORR)	0 participants Not estimable due to no responders	1 participants Interval 0.1 to 20.4	0 participants Not estimable due to no responders	0 participants Not estimable due to no responders	1 participants Interval 0.4 to 57.9	0 participants Not estimable due to no responders

Adverse Events

Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Chronic Myelomonocytic Leukemia

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia

Serious events: 23 serious events

Other events: 39 other events

Deaths: 26 deaths

Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis

Serious events: 20 serious events

Other events: 35 other events

Deaths: 21 deaths

Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Advanced Systemic Mastocytosis

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Chronic Myelomonocytic Leukemia n=1 participants at risk Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia n=2 participants at risk Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia n=39 participants at risk Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis n=2 participants at risk Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis n=1 participants at risk Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis n=36 participants at risk Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Advanced Systemic Mastocytosis n=1 participants at risk Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
Cardiac disorders Cardiopulmonary failure	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Multiple organ dysfunction syndrome	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Pyrexia	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary tract disorder	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Vascular disorders Capillary leak syndrome	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	15.4% 6/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Vascular disorders Embolism	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Vascular disorders Shock haemorrhagic	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Pancreatitis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Hepatobiliary disorders Cholecystitis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Hepatobiliary disorders Cholelithiasis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Cellulitis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Clostridium difficile colitis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Lung infection	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Parotitis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia pseudomonal	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Tracheobronchitis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Cerebral infarction	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Cerebrovascular accident	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Presyncope	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Surgical and medical procedures Nasal cavity packing	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Cardiac disorders Atrial thrombosis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Cardiac disorders Supraventricular tachycardia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Cardiac disorders Tachycardia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Cardiac disorders Ventricular arrhythmia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastric perforation	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastric polyps	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Generalised oedema	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Orchitis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/29 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.0% 1/20 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Sepsis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Septic shock	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Vulvitis	— 0/0 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/10 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	6.2% 1/16 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	— 0/0 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Dementia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Haemorrhage intracranial	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Psychiatric disorders Confusional state	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Laryngeal injury	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Vascular disorders Deep vein thrombosis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Cardiac disorders Pericardial effusion	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Stroke	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Cardiac disorders Cardiac failure	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Haematotympanum	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Chronic Myelomonocytic Leukemia n=1 participants at risk Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia n=2 participants at risk Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia n=39 participants at risk Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis n=2 participants at risk Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis n=1 participants at risk Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis n=36 participants at risk Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.	Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Advanced Systemic Mastocytosis n=1 participants at risk Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	43.6% 17/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 2/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	22.2% 8/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	28.2% 11/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Leukopenia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	23.1% 9/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	25.0% 9/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Cardiac disorders Palpitations	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Cardiac disorders Pericardial effusion	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Cardiac disorders Sinus tachycardia	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	15.4% 6/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Cardiac disorders Tachycardia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	12.8% 5/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Cardiac disorders Ventricular tachycardia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Eye disorders Vision blurred	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	12.8% 5/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	22.2% 8/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	35.9% 14/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	27.8% 10/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	35.9% 14/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	25.0% 9/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	12.8% 5/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Flatulence	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gingival bleeding	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gingival pain	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Haematochezia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Haemorrhoids	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Melaena	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	43.6% 17/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	41.7% 15/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Toothache	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 2/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	25.6% 10/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	27.8% 10/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Asthenia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	12.8% 5/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	16.7% 6/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Chest discomfort	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Chest pain	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	13.9% 5/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Chills	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	28.2% 11/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	27.8% 10/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Early satiety	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	11.1% 4/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Fatigue	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	46.2% 18/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	25.0% 9/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Gait disturbance	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Generalised oedema	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Influenza like illness	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Nodule	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Non-cardiac chest pain	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Oedema	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Oedema peripheral	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 2/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	30.8% 12/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	33.3% 12/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Pain	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	17.9% 7/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Peripheral swelling	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	25.6% 10/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	30.6% 11/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Appendicitis	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Immune system disorders Cytokine release syndrome	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	11.1% 4/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Cellulitis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Clostridium difficile infection	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Enterococcal infection	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Lung infection	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Herpes virus infection	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Oral herpes	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Sepsis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Sinusitis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	13.9% 5/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	11.1% 4/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	12.8% 5/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	11.1% 4/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	11.1% 4/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Laceration	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	28.2% 11/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	22.2% 8/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	23.1% 9/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	16.7% 6/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Investigations Blood alkaline phosphatase increased	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Investigations Blood creatinine increased	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	23.1% 9/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	11.1% 4/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Investigations Neutrophil count decreased	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Investigations Platelet count decreased	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	23.1% 9/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Investigations Transaminases increased	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Investigations Weight decreased	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	13.9% 5/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Investigations Weight increased	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	30.8% 12/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	22.2% 8/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	38.5% 15/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	30.6% 11/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Fluid overload	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Fluid retention	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	20.5% 8/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	16.7% 6/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	12.8% 5/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	11.1% 4/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	13.9% 5/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	46.2% 18/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	47.2% 17/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	17.9% 7/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	43.6% 17/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	22.2% 8/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	16.7% 6/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	15.4% 6/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	20.5% 8/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	19.4% 7/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	35.9% 14/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	11.1% 4/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	15.4% 6/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	20.5% 8/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	11.1% 4/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	13.9% 5/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	23.1% 9/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	30.6% 11/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Dysgeusia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Headache	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 2/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	28.2% 11/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	27.8% 10/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Peripheral sensory neuropathy	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Restless legs syndrome	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Tremor	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Diabetic neuropathy	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Memory impairment	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Somnolence	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Psychiatric disorders Agitation	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Psychiatric disorders Anxiety	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	11.1% 4/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Psychiatric disorders Confusional state	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	16.7% 6/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Psychiatric disorders Depression	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Psychiatric disorders Emotional distress	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Psychiatric disorders Insomnia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	23.1% 9/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	16.7% 6/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Psychiatric disorders Restlessness	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Psychiatric disorders Sleep disorder	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Psychiatric disorders Mental status changes	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	23.1% 9/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Renal and urinary disorders Dysuria	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Renal and urinary disorders Polyuria	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Renal and urinary disorders Pollakiuria	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary incontinence	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	38.5% 15/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	16.7% 6/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	30.8% 12/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	36.1% 13/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	16.7% 6/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	12.8% 5/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	16.7% 6/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 2/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	13.9% 5/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	13.9% 5/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Vascular disorders Capillary leak syndrome	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	7.7% 3/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Vascular disorders Embolism	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	10.3% 4/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Vascular disorders Flushing	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.1% 2/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	11.1% 4/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Vascular disorders Haematoma	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	12.8% 5/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	8.3% 3/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Vascular disorders Hypotension	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	23.1% 9/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	27.8% 10/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Vascular disorders Deep vein thrombosis	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Vascular disorders Petechiae	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Hiccups	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	50.0% 1/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	5.6% 2/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Investigations Electrocardiogram QT prolonged	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Head discomfort	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Nervous system disorders Migraine	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.6% 1/39 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/2 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	0.00% 0/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	2.8% 1/36 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.	100.0% 1/1 • Up to 1145 days All reported safety data based upon Safety Population: All participants who received at least 1 dose of study drug.

Additional Information

Ira Gupta, MD

Stemline Therapeutics, Inc.

Phone: 1-877-332-7967

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 1. Individual site results may be submitted for publication only after the results of the multicenter study are published, 12 months after study completion at all sites, or notification from Stemline that submission of a multicenter publication is no longer planned. 2. Thereafter, the PI is free to publish the results. 3. The PI is required to furnish Stemline with a copy of any proposed publication or presentation for review and comment at least thirty (30) days prior to submission.
Publication restrictions are in place

Restriction type: OTHER