Trial Outcomes & Findings for Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients (NCT NCT00598702)

NCT ID: NCT00598702

Last Updated: 2017-05-10

Results Overview

A TEAE is defined as an adverse event that starts on or after the start of study medication.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 100 participants
• Primary outcome timeframe: First dose to end of treatment period
• Results posted on: 2017-05-10

Participant Flow

Multi-center study conducted in the United States from 19 Mar 2008 - 24Dec 2008

No subjects were entered into the "Infants (29 days to 1 year old): IV APAP 6.7 - 12.5 mg/kg q4h" group

Participant milestones

Measure	Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours	Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h Children 2 to \< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h Children 2 to \< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h Adolescents 12 to \<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h Adolescents 12 to \<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h Infants 12 to \< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h Infants 12 to \< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
Overall Study STARTED	1	3	7	33	9	42	1	4
Overall Study COMPLETED	1	1	5	25	6	30	0	4
Overall Study NOT COMPLETED	0	2	2	8	3	12	1	0

Reasons for withdrawal

Measure	Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours	Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h Children 2 to \< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h Children 2 to \< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h Adolescents 12 to \<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h Adolescents 12 to \<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h Infants 12 to \< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h Infants 12 to \< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
Overall Study Other	0	2	0	0	0	1	0	0
Overall Study Early discharge from hospital	0	0	2	5	0	10	1	0
Overall Study Adverse Event	0	0	0	1	0	0	0	0
Overall Study Withdrawal by Subject	0	0	0	1	1	0	0	0
Overall Study Physician Decision	0	0	0	0	1	0	0	0
Overall Study Dose limiting toxicity	0	0	0	1	1	1	0	0

Baseline Characteristics

Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients

Baseline characteristics by cohort

Measure	Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h n=1 Participants Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours	Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h n=3 Participants Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h n=7 Participants Children 2 to \< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h n=33 Participants Children 2 to \< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h n=9 Participants Adolescents 12 to \<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h n=42 Participants Adolescents 12 to \<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h n=1 Participants Infants 12 to \< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h n=4 Participants Infants 12 to \< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	33 Participants n=4 Participants	9 Participants n=21 Participants	42 Participants n=8 Participants	1 Participants n=8 Participants	4 Participants n=24 Participants	100 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants	6 Participants n=21 Participants	29 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants	62 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	16 Participants n=4 Participants	3 Participants n=21 Participants	13 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	38 Participants n=42 Participants

PRIMARY outcome

Timeframe: First dose to end of treatment period

Population: All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.

A TEAE is defined as an adverse event that starts on or after the start of study medication.

Outcome measures

Measure	Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h n=1 Participants Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours	Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h n=3 Participants Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h n=7 Participants Children 2 to \< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h n=33 Participants Children 2 to \< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h n=9 Participants Adolescents 12 to \<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h n=42 Participants Adolescents 12 to \<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h n=1 Participants Infants 12 to \< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h n=4 Participants Infants 12 to \< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)	1 Subjects	1 Subjects	5 Subjects	25 Subjects	9 Subjects	35 Subjects	0 Subjects	2 Subjects

PRIMARY outcome

Timeframe: First dose to 30 days after last dose

Population: All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.

A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP that;

• results in death
• is life-threatening
• requires inpatient hospitalization or causes prolongation of existing hospitalization
• results in persistent or significant disability/incapacity
• is a congenital anomaly/birth defect
• is an important medical event

Outcome measures

Measure	Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h n=1 Participants Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours	Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h n=3 Participants Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h n=7 Participants Children 2 to \< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h n=33 Participants Children 2 to \< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h n=9 Participants Adolescents 12 to \<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h n=42 Participants Adolescents 12 to \<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h n=1 Participants Infants 12 to \< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h n=4 Participants Infants 12 to \< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event	1 Subjects	1 Subjects	0 Subjects	13 Subjects	2 Subjects	3 Subjects	0 Subjects	1 Subjects

SECONDARY outcome

Timeframe: Day 0 to Day 5, Day 7 or Early Termination from study

Population: All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.

Subject's (parent/guardian) was asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair, 2=good, 3= excellent).

Outcome measures

Measure	Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h n=1 Participants Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours	Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h n=3 Participants Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h n=7 Participants Children 2 to \< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h n=33 Participants Children 2 to \< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h n=9 Participants Adolescents 12 to \<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h n=42 Participants Adolescents 12 to \<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h n=1 Participants Infants 12 to \< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h n=4 Participants Infants 12 to \< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
Subject's (Parent/Guardian) Global Evaluation of Study Treatment Poor	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Subject's (Parent/Guardian) Global Evaluation of Study Treatment Fair	0 participants	0 participants	0 participants	0 participants	1 participants	2 participants	0 participants	0 participants
Subject's (Parent/Guardian) Global Evaluation of Study Treatment Good	0 participants	3 participants	1 participants	11 participants	3 participants	17 participants	0 participants	1 participants
Subject's (Parent/Guardian) Global Evaluation of Study Treatment Excellent	1 participants	0 participants	6 participants	17 participants	5 participants	23 participants	1 participants	2 participants
Subject's (Parent/Guardian) Global Evaluation of Study Treatment Missing	0 participants	0 participants	0 participants	5 participants	0 participants	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: End of study or Early Termination

Population: All analysis will be carried out using the safety population, defined as all subjects who received at least one dose of study medication.

Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent).

Outcome measures

Measure	Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h n=1 Participants Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours	Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h n=3 Participants Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h n=7 Participants Children 2 to \< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h n=33 Participants Children 2 to \< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h n=9 Participants Adolescents 12 to \<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h n=42 Participants Adolescents 12 to \<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h n=1 Participants Infants 12 to \< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h n=4 Participants Infants 12 to \< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
Physician's Global Assessment of Study Treatment Missing	0 participants	0 participants	0 participants	5 participants	0 participants	0 participants	0 participants	1 participants
Physician's Global Assessment of Study Treatment Poor	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Physician's Global Assessment of Study Treatment Fair	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants
Physician's Global Assessment of Study Treatment Good	0 participants	2 participants	1 participants	15 participants	4 participants	16 participants	0 participants	1 participants
Physician's Global Assessment of Study Treatment Excellent	1 participants	1 participants	6 participants	13 participants	5 participants	25 participants	1 participants	2 participants

Adverse Events

Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h

Serious events: 13 serious events

Other events: 24 other events

Deaths: 0 deaths

Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h

Serious events: 3 serious events

Other events: 33 other events

Deaths: 0 deaths

Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h n=1 participants at risk Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours	Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h n=3 participants at risk Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h n=7 participants at risk Children 2 to \< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h n=33 participants at risk Children 2 to \< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h n=9 participants at risk Adolescents 12 to \<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h n=42 participants at risk Adolescents 12 to \<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h n=1 participants at risk Infants 12 to \< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h n=4 participants at risk Infants 12 to \< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Nervous system disorders Neuralgia	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	2.4% 1/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Infections and infestations Abdominal abscess	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	6.1% 2/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Diaphragmatic disorder	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Nervous system disorders Headache	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	11.1% 1/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Investigations Hepatic enzyme increased	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	6.1% 2/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	2.4% 1/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	11.1% 1/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Infections and infestations Postoperative wound infection	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Renal and urinary disorders Renal failure acute	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	2.4% 1/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	33.3% 1/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	6.1% 2/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Congenital, familial and genetic disorders Congenital Megacolon	100.0% 1/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Cardiac disorders Hypotension	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	2.4% 1/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
General disorders Pyrexia	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	2.4% 1/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
General disorders Catheter-Related Complication	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Infections and infestations Wound Infection	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	6.1% 2/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.

Other adverse events

Measure	Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h n=1 participants at risk Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours	Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h n=3 participants at risk Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h n=7 participants at risk Children 2 to \< 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h n=33 participants at risk Children 2 to \< 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h n=9 participants at risk Adolescents 12 to \<= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h n=42 participants at risk Adolescents 12 to \<= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours	Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h n=1 participants at risk Infants 12 to \< 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours	Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h n=4 participants at risk Infants 12 to \< 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
Infections and infestations Abdominal abscess	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Psychiatric disorders Agitation	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	9.1% 3/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	50.0% 2/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Blood and lymphatic system disorders Anemia	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	33.3% 1/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	14.3% 1/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	6.1% 2/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	4.8% 2/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	33.3% 11/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	22.2% 2/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	23.8% 10/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	28.6% 2/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	9.1% 3/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	4.8% 2/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Nervous system disorders Headache	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	33.3% 3/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	9.5% 4/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Vascular disorders Hypertension	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	12.1% 4/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	11.1% 1/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	6.1% 2/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	11.1% 1/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	2.4% 1/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Vascular disorders Hypotension	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	15.2% 5/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	11.1% 1/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
General disorders Inflammation	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Psychiatric disorders Insomnia	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	6.1% 2/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Laryngotracheal oedema	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	22.2% 2/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	9.5% 4/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	42.9% 3/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	18.2% 6/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	55.6% 5/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	40.5% 17/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Renal and urinary disorders Oliguria	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	33.3% 1/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	2.4% 1/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Renal and urinary disorders Polyuria	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	28.6% 2/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	15.2% 5/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	44.4% 4/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	9.5% 4/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
General disorders Pyrexia	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	21.2% 7/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	7.1% 3/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Skin and subcutaneous tissue disorders Skin irritation	100.0% 1/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Investigations Sputum culture positive	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	9.1% 3/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	33.3% 1/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	28.6% 2/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	21.2% 7/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	44.4% 4/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	23.8% 10/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	25.0% 1/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	50.0% 2/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Cardiac disorders Tachycardia	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	6.1% 2/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	2.4% 1/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Ear and labyrinth disorders Ear Pain	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	14.3% 1/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Gastrointestinal disorders Abdominal Distension	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	6.1% 2/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Gastrointestinal disorders Abdominal Pain	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	14.3% 1/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	3.0% 1/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	2.4% 1/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
General disorders Infusion Site Reaction	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	11.1% 1/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
General disorders Oedema Peripheral	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	9.1% 3/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	2.4% 1/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Infections and infestations Cellulitis	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	14.3% 1/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Infections and infestations Vulvovaginal Mycotic Infection	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	11.1% 1/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Investigations Gamma-Glutamyltransferase (GGT) Increased	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	11.1% 1/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	6.1% 2/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	4.8% 2/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	14.3% 1/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	6.1% 2/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Nervous system disorders Dizziness	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	7.1% 3/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Renal and urinary disorders Urinary Retention	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	14.3% 1/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	11.1% 1/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	6.1% 2/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	11.1% 1/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	22.2% 2/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	6.1% 2/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	6.1% 2/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Skin and subcutaneous tissue disorders Rash Generalised	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	14.3% 1/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Surgical and medical procedures Wound Drainage	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	11.1% 1/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.
Nervous system disorders Sedation	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/3 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/7 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/33 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	11.1% 1/9 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/42 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/1 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.	0.00% 0/4 • Non-serious treatment emergent adverse events (TEAEs) were collected from the initiation of treatment with study medication to the end of the patient's treatment period. Serious adverse events (SAEs) were collected from the initiation of study medication through 30 days of the last dose of study drug.

Additional Information

Lawrence Hill, VP Clinical Development

Mallinckrodt Pharmaceuticals

Phone: 908-238-6370

Email: lawrence.hill@mallinckrodt.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Investigator may publish 18 months after Cadence's final evaluation of all study data from all sites, whichever occurs first.Manuscripts/abstracts will be provided to Cadence for review and comment at least 30 days prior to submission.Cadence shall have 30 days to respond with comments.
• Publication restrictions are in place

Restriction type: OTHER