Trial Outcomes & Findings for A Study of Brequinar in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (NCT NCT03760666)

NCT ID: NCT03760666

Last Updated: 2022-08-08

Results Overview

The number of participants with grade 3 or greater treatment-related adverse events as assessed by CTCAE v. 4.03.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2022-08-08

Participant Flow

Cohort 1 (N = 5) 12/20/2018 - 04/01/2019. Cohort 2 (N = 11) 10/25/2019 - 11/20/2020. Cohort 3 (N = 1) 01/12/21 - 02/03/2021. Participants were enrolled at hematology oncology units at major hospitals. Only 17 of the 27 planned participants were enrolled due to lack of efficacy with either brequinar monotherapy or the brequinar + ribavirin combination. Participants were to be treated in the study for up to one year.

All subjects had relapsed/refractory AML and had no other viable treatment options. Data were reported and analyzed by cohort.

Participant milestones

Measure	Cohort 1 5 subjects were enrolled in this cohort and started dosing at 500 mg/m2 twice weekly	Cohort 2 Six (6) Cohort 2 subjects started dosing with brequinar monotherapy at 500 mg/m2 on a once-weekly basis and five (5) Cohort 2 subjects started dosing with brequinar monotherapy at 350 mg/m2 on a once-weekly basis.	Cohort 3 One subject was enrolled into this cohort and started dosing with brequinar monotherapy at 350 mg/m2 on a once-weekly basis. Ribavirin was added at 1000 mg p.o. BID.
Overall Study STARTED	5	11	1
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	5	11	1

Reasons for withdrawal

Measure	Cohort 1 5 subjects were enrolled in this cohort and started dosing at 500 mg/m2 twice weekly	Cohort 2 Six (6) Cohort 2 subjects started dosing with brequinar monotherapy at 500 mg/m2 on a once-weekly basis and five (5) Cohort 2 subjects started dosing with brequinar monotherapy at 350 mg/m2 on a once-weekly basis.	Cohort 3 One subject was enrolled into this cohort and started dosing with brequinar monotherapy at 350 mg/m2 on a once-weekly basis. Ribavirin was added at 1000 mg p.o. BID.
Overall Study Adverse Event	2	4	1
Overall Study AML Disease Progression	3	3	0
Overall Study Physician Decision	0	3	0
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

A Study of Brequinar in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Baseline characteristics by cohort

Measure	Cohort 1 n=5 Participants 5 subjects were enrolled in this cohort and started dosing at 500 mg/m2 twice weekly.	Cohort 2 n=11 Participants Six (6) Cohort 2 subjects started dosing with brequinar monotherapy at 500 mg/m2 on a once-weekly basis and five (5) Cohort 2 subjects started dosing with brequinar monotherapy at 350 mg/m2 on a once-weekly basis.	Cohort 3 n=1 Participants One subject was enrolled into this cohort and started dosing with brequinar monotherapy at 350 mg/m2 on a once-weekly basis. Ribavirin was added at 1000 mg p.o. BID.	Total n=17 Participants Total of all reporting groups
Age, Continuous	60.4 years STANDARD_DEVIATION 20.89 • n=5 Participants	72.5 years STANDARD_DEVIATION 7.13 • n=7 Participants	66.0 years STANDARD_DEVIATION 0 • n=5 Participants	68.8 years STANDARD_DEVIATION 13.15 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	1 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	10 Participants n=7 Participants	1 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	11 participants n=7 Participants	1 participants n=5 Participants	17 participants n=4 Participants
Body Surface Area	1.94 meters squared STANDARD_DEVIATION 0.126 • n=5 Participants	1.82 meters squared STANDARD_DEVIATION 0.306 • n=7 Participants	2.0 meters squared STANDARD_DEVIATION 0 • n=5 Participants	1.86 meters squared STANDARD_DEVIATION 0.259 • n=4 Participants
ECOG (European Cooperative Oncology Group ECOG Score of 0	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
ECOG (European Cooperative Oncology Group ECOG Score of 1	2 Participants n=5 Participants	9 Participants n=7 Participants	0 Participants n=5 Participants	11 Participants n=4 Participants
ECOG (European Cooperative Oncology Group ECOG Score of 2	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The Safety Population was used for this analysis. The Safety Population consisted of all subjects who were enrolled in the study and received at least one dose of brequinar. Data were reported and analyzed by cohort.

The number of participants with grade 3 or greater treatment-related adverse events as assessed by CTCAE v. 4.03.

Outcome measures

Measure	Cohort 1 n=5 Participants The 5 subjects in Cohort 1 started dosing with brequinar monotherapy at 500 mg/m2 on a twice-weekly basis.	Cohort 2 n=11 Participants A total of 11 subjects were enrolled into Cohort 2. Six (6) Cohort 2 subjects started dosing with brequinar monotherapy at 500 mg/m2 on a once-weekly basis and five (5) Cohort 2 subjects started dosing with brequinar monotherapy at 350 mg/m2 on a once-weekly basis.	Cohort 3 n=1 Participants One subject was enrolled into this cohort and started dosing with brequinar monotherapy at 350 mg/m2 on a once-weekly basis. Ribavirin was added at 1000 mg p.o. BID.
Number of Participants With Treatment-Related Adverse Events	2 Participants	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 months

Population: The Efficacy Analysis Set was a subset of the Safety population with measurable AML disease at baseline and at least one post-baseline disease response assessment. No subjects achieved this status. Data were reported and analyzed by cohort.

The number of participants in the Efficacy Analysis Set with best overall response of one of the responses of CR, CRi, CRh, PR, of MLFS. No participant met the efficacy endpoint to be included in this analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 12 months

Population: The Efficacy Analysis Set was a subset of the Safety population with measurable AML disease at baseline and at least one post-baseline disease response assessment. No subjects achieved this status. Data were reported and analyzed by cohort.

The proportion of subjects in the Efficacy Analysis Set with best overall response of CR. No participant met this efficacy endpoint to be included in this analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 12 months

Population: The Efficacy Analysis Set was a subset of the Safety population with measurable AML disease at baseline and at least one post-baseline disease response assessment. No subjects achieved this status. Data were reported and analyzed by cohort.

The proportion of subjects in the Efficacy Analysis Set with a best overall response of CRi. No participant met this efficacy endpoint to be included in this analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 12 months

Population: The Efficacy Analysis Set was a subset of the Safety population with measurable AML disease at baseline and at least one post-baseline disease response assessment. No subjects achieved this status. Data were reported and analyzed by cohort.

The proportion of subjects in the Efficacy Analysis Set with a best overall response of CRh. No participant met this efficacy endpoint to be included in this analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 12 months

Population: The Efficacy Analysis Set was a subset of the Safety population with measurable AML disease at baseline and at least one post-baseline disease response assessment. No subjects achieved this status. Data were reported and analyzed by cohort.

The proportion of subjects in the Efficacy Analysis Set with a best overall response of MLFS. No participant met this efficacy endpoint to be included in this analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 12 months

Population: The Efficacy Analysis Set was a subset of the Safety population with measurable AML disease at baseline and at least one post-baseline disease response assessment. No subjects achieved this status. Data were reported and analyzed by cohort.

The proportion of subjects in the Efficacy Analysis Set with a best overall response of PR. No participant met this efficacy endpoint to be included in this analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 12 months

Population: The Efficacy Analysis Set was a subset of the Safety population with measurable AML disease at baseline and at least one post-baseline disease response assessment. No subjects achieved this status. Data were reported and analyzed by cohort.

Interval between first dose and relapse (>=5% bone marrow blasts, reappearance of blasts in blood, or development of extramedullary disease), disease progression, or both. No participant met this efficacy endpoint to be included in this analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 12 months

Population: Subjects with a response. No subjects achieved this status. Data were reported and analyzed by cohort.

The duration of response is defined as the number of days from the time response criteria are initially met for CR, CRi, CRh, PR, or MLFS (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, or death due to any cause. Participants without events reported are censored at the last disease evaluation. No participant met this efficacy endpoint to be included in this analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: First day of dosing: baseline (pre-dose), 1 hour, 2 hours, 4 hours, 6 hours.

Population: This population included subjects who completed at least Week 1 of the study. Results are based on Week 1 samples obtained on the first day of dosing at baseline (pre-dose) then at Hour 1, 2, 4, and 6. Data were reported and analyzed by cohort.

The plot of drug concentration in blood plasma vs. time.

Outcome measures

Measure	Cohort 1 n=5 Participants The 5 subjects in Cohort 1 started dosing with brequinar monotherapy at 500 mg/m2 on a twice-weekly basis.	Cohort 2 n=11 Participants A total of 11 subjects were enrolled into Cohort 2. Six (6) Cohort 2 subjects started dosing with brequinar monotherapy at 500 mg/m2 on a once-weekly basis and five (5) Cohort 2 subjects started dosing with brequinar monotherapy at 350 mg/m2 on a once-weekly basis.	Cohort 3 n=1 Participants One subject was enrolled into this cohort and started dosing with brequinar monotherapy at 350 mg/m2 on a once-weekly basis. Ribavirin was added at 1000 mg p.o. BID.
Brequinar Pharmacokinetics - Area Under the Curve (AUC)	501.0 micrograms.hr/mL Standard Deviation 354.5	546.5 micrograms.hr/mL Standard Deviation 564.1	130.5 micrograms.hr/mL Standard Deviation 0.0

Adverse Events

Cohort 1

Serious events: 3 serious events

Other events: 5 other events

Deaths: 3 deaths

Cohort 2

Serious events: 6 serious events

Other events: 11 other events

Deaths: 3 deaths

Cohort 3

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort 1 n=5 participants at risk 5 subjects were enrolled in this cohort and started dosing at 500 mg/m2 twice weekly.	Cohort 2 n=11 participants at risk Six (6) Cohort 2 subjects started dosing with brequinar monotherapy at 500 mg/m2 on a once-weekly basis and five (5) Cohort 2 subjects started dosing with brequinar monotherapy at 350 mg/m2 on a once-weekly basis.	Cohort 3 n=1 participants at risk One subject was enrolled into this cohort and started dosing with brequinar monotherapy at 350 mg/m2 on a once-weekly basis. Ribavirin was added at 1000 mg p.o. BID.
Blood and lymphatic system disorders Febrile Neutropenia	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Diarrhea	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Stomatitis	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
General disorders Death	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
General disorders Mucosal inflammation	40.0% 2/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Infections and infestations Bacteremia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	100.0% 1/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Infections and infestations Cellulitis	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Infections and infestations Lung infection	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Infections and infestations Pneumonia	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Infections and infestations Urinary tract infection	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Investigations Blood creatinine increased	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Musculoskeletal and connective tissue disorders Back pain	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Nervous system disorders Intracranial hematoma	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.

Other adverse events

Measure	Cohort 1 n=5 participants at risk 5 subjects were enrolled in this cohort and started dosing at 500 mg/m2 twice weekly.	Cohort 2 n=11 participants at risk Six (6) Cohort 2 subjects started dosing with brequinar monotherapy at 500 mg/m2 on a once-weekly basis and five (5) Cohort 2 subjects started dosing with brequinar monotherapy at 350 mg/m2 on a once-weekly basis.	Cohort 3 n=1 participants at risk One subject was enrolled into this cohort and started dosing with brequinar monotherapy at 350 mg/m2 on a once-weekly basis. Ribavirin was added at 1000 mg p.o. BID.
Blood and lymphatic system disorders anemia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Blood and lymphatic system disorders Febrile Neutropenia	40.0% 2/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Blood and lymphatic system disorders Thrombocytopenia	40.0% 2/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Cardiac disorders Atrial fibrillation	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Cardiac disorders Sinus bradycardia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Cardiac disorders Sinus tachycardia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	36.4% 4/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Eye disorders Vision blurred	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Abdominal distension	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Constipation	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	100.0% 1/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Diarrhea	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	45.5% 5/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Dyspepsia	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Hemorrhoids	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Large intestine perforation	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Lip blister	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Nausea	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	45.5% 5/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Oral pain	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Stomatitis	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	27.3% 3/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Tongue erythema	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Toothache	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Gastrointestinal disorders Vomiting	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	27.3% 3/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
General disorders Fatigue	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	36.4% 4/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	100.0% 1/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
General disorders Gait disturbance	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
General disorders Mucosal inflammation	40.0% 2/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	100.0% 1/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
General disorders Non-cardiac chest pain	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
General disorders Edema peripheral	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	27.3% 3/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
General disorders Pain	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
General disorders Pyrexia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Infections and infestations Cellulitis	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Infections and infestations Clostridium difficile colitis	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Infections and infestations Corona virus infection	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	100.0% 1/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Infections and infestations Lung infection	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Infections and infestations Pneumonia	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Infections and infestations Pneumonia fungal	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Infections and infestations Sepsis	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Infections and infestations Skin infection	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Infections and infestations Urinary tract infection	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Injury, poisoning and procedural complications Animal scratch	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Injury, poisoning and procedural complications Contusion	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	27.3% 3/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Injury, poisoning and procedural complications Fall	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	36.4% 4/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Injury, poisoning and procedural complications Incision site rash	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Injury, poisoning and procedural complications Limb injury	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Injury, poisoning and procedural complications Skin wound	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	100.0% 1/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Investigations Alanine aminotransferase increased	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Investigations Aspartate aminotransferase increased	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Investigations Blood alkaline phosphatase increased	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Investigations Blood bilirubin increased	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Investigations Blood creatinine increased	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	27.3% 3/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Investigations Hepatic enzyme increased	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Investigations Urine output decreased	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Investigations Weight decreased	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	36.4% 4/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	100.0% 1/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Fluid retention	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	27.3% 3/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	36.4% 4/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	36.4% 4/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	27.3% 3/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	100.0% 1/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	36.4% 4/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	100.0% 1/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	27.3% 3/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Metabolism and nutrition disorders Malnutrition	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Musculoskeletal and connective tissue disorders Back pain	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	100.0% 1/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Musculoskeletal and connective tissue disorders Muscular weakness	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hemangioma of skin	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Nervous system disorders Dizziness	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Nervous system disorders Dysgeusia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Nervous system disorders Headache	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Nervous system disorders Memory impairment	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Nervous system disorders Migraine with aura	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Nervous system disorders Somnolence	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Nervous system disorders Syncope	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	100.0% 1/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Psychiatric disorders Agitation	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Nervous system disorders Confusional state	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Nervous system disorders Depression	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Nervous system disorders Restlessness	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Renal and urinary disorders Dysuria	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Renal and urinary disorders Micturition urgency	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Renal and urinary disorders Pollakiuria	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	100.0% 1/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Renal and urinary disorders Urinary incontinence	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	36.4% 4/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	100.0% 1/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	36.4% 4/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	54.5% 6/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Respiratory, thoracic and mediastinal disorders Hypoxia	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Respiratory, thoracic and mediastinal disorders Pleural effusion	20.0% 1/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Skin and subcutaneous tissue disorders Petechia	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Skin and subcutaneous tissue disorders Rash	40.0% 2/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Skin and subcutaneous tissue disorders Rash maculopapular	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	18.2% 2/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Skin and subcutaneous tissue disorders Skin hemorrhage	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	9.1% 1/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Vascular disorders Hypertension	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	27.3% 3/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.
Vascular disorders Hypotension	0.00% 0/5 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	27.3% 3/11 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.	0.00% 0/1 • up to 1 year An adverse event is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Events that occur prior to dosing will be entered as medical history; AEs that occur after dosing will be entered on the AE form. Subjects will be questioned and observed for evidence of AEs, whether or not related to study drug. Data were reported and analyzed by cohort.

Additional Information

Vice President, Clinical Operations

Clear Creek Bio, Inc.

Phone: (617) 765-2252

Email: clinical@clearcreekbio.com

Results disclosure agreements

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