Trial Outcomes & Findings for An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain (NCT NCT00465647)

Last Updated: 2015-11-18

Results Overview

Model was built using sparse blood samples: Sampling times: immediately predose, and between 0.25-0.75, 1-3, and 4-6 hours postdose for the first 2 doses of oral hydromorphone: predose for each dose of oral hydromorphone HCl thereafter; and at the end of study. Efficacy was based on Oral treatment only.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

116 participants

Primary outcome timeframe

A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.

Results posted on

2015-11-18

Participant Flow

23-Apr-2007 (first subject, first visit) to 03-May-2009 (last subject, last visit). Multicenter study conducted at 18 sites in the United States (US).

Subjects who were anticipated to have acute, postoperative pain requiring oral opioid analgesics for at least 24 to 48 hours following postoperative parenteral analgesia.

Participant milestones

Participant milestones
Measure	≥ 28 Days to < 13 Months Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	≥ 13 Months to < 5 Years Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	≥ 5 Years to <12 Years Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	≥ 12 Years to < 17 Years Adolescent- received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
Overall Study STARTED	39	23	29	25
Overall Study COMPLETED	26	15	18	12
Overall Study NOT COMPLETED	13	8	11	13

Reasons for withdrawal

Reasons for withdrawal
Measure	≥ 28 Days to < 13 Months Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	≥ 13 Months to < 5 Years Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	≥ 5 Years to <12 Years Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	≥ 12 Years to < 17 Years Adolescent- received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
Overall Study Administrative	2	2	3	2
Overall Study Adverse Event	2	0	3	2
Overall Study Withdrawal by Subject	1	2	2	7
Overall Study The "other" reasons included loss of IV	8	4	3	2

Baseline Characteristics

An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	≥ 28 Days to < 13 Months n=39 Participants Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	≥ 13 Months to < 5 Years n=23 Participants Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	≥ 5 Years to < 12 Years n=29 Participants Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	≥ 12 Years to < 17 Years n=25 Participants Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Total n=116 Participants Total of all reporting groups
Age, Continuous	5.9 months STANDARD_DEVIATION 2.76 • n=5 Participants	33.6 months STANDARD_DEVIATION 14.90 • n=7 Participants	105.9 months STANDARD_DEVIATION 27.06 • n=5 Participants	178.3 months STANDARD_DEVIATION 17.05 • n=4 Participants	73.5 months STANDARD_DEVIATION 69.32 • n=21 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants	18 Participants n=4 Participants	60 Participants n=21 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants	7 Participants n=4 Participants	56 Participants n=21 Participants
Race/Ethnicity, Customized Asian	5 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	9 participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Black or African American	6 participants n=5 Participants	2 participants n=7 Participants	10 participants n=5 Participants	5 participants n=4 Participants	23 participants n=21 Participants
Race/Ethnicity, Customized White	28 participants n=5 Participants	16 participants n=7 Participants	18 participants n=5 Participants	20 participants n=4 Participants	82 participants n=21 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants

PRIMARY outcome

Timeframe: A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.

Population: The full analysis population for Pharmacokinetics/ Pharmacodynamics consisted of subjects who received at least 1 dose of oral hydromorphone HCl, and had at least 1 valid quantifiable PK sample. To be a valid sample, the time of administration of each dose of oral hydromorphone HCl, the dose, and the time of sample collection must be recorded.

Outcome measures

Outcome measures
Measure	All Patients n=99 Participants A total of all 4 age groups: infant and toddler, young child, older child, and adolescent.	Oral ≥ 13 Months to < 5 Years Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Oral ≥ 5 Years to < 12 Years Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Oral ≥ 12 Years to < 17 Years Adolescent (Data for this group not collected. Test not appropriate for this age)
Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)	114 L/hour Interval 80.6 to 203.0	—	—	—

SECONDARY outcome

Timeframe: Immediately prior to first oral dose, up to 54 hours

Population: The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).

There are 5 categories in this pediatric pain measurement: face, legs, activity, cry, and consolability. Responses in each category are scored between 0 and 2 (0 = normal, relaxed to 2 = upset, agitated), for a maximum total score of 10. The FLACC scale was used for children under the age of 3 years and older children who have limited verbal skills.

Outcome measures

Outcome measures
Measure	All Patients n=33 Participants A total of all 4 age groups: infant and toddler, young child, older child, and adolescent.	Oral ≥ 13 Months to < 5 Years n=21 Participants Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Oral ≥ 5 Years to < 12 Years n=26 Participants Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Oral ≥ 12 Years to < 17 Years Adolescent (Data for this group not collected. Test not appropriate for this age)
Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] Predose	1.34 units on a scale Standard Error 0.388	2.67 units on a scale Standard Error 0.558	2.71 units on a scale Standard Error 0.522	—
Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] Dose 1 (1 hour postdose)	1.13 units on a scale Standard Error 0.335	1.07 units on a scale Standard Error 0.483	2.17 units on a scale Standard Error 0.872	—
Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] Dose 2 (1 hour postdose)	0.57 units on a scale Standard Error 0.223	0.67 units on a scale Standard Error 0.333	1.20 units on a scale Standard Error 0.583	—
Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] Dose 3 (1 hour postdose)	0.27 units on a scale Standard Error 0.117	0.93 units on a scale Standard Error 0.715	0.75 units on a scale Standard Error 0.750	—
Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] Dose 4 (1 hour postdose)	0.55 units on a scale Standard Error 0.274	0.85 units on a scale Standard Error 0.608	0.40 units on a scale Standard Error 0.400	—
Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] Dose 5 (1 hour postdose)	0.70 units on a scale Standard Error 0.333	0.09 units on a scale Standard Error 0.091	1.00 units on a scale Standard Error 0.577	—
Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] Dose 6 (1 hour postdose)	0.61 units on a scale Standard Error 0.465	1.20 units on a scale Standard Error 0.854	0.75 units on a scale Standard Error 0.479	—

SECONDARY outcome

Timeframe: Immediately prior to first oral dose with potentially up to 54 hours duration.

Faces Pain Scale-Revised (FPS-R) consists of 6 facial expressions. Each face is 25 x 35 mm with 13 mm between faces. Each subject was asked to point to the face that reflected his or her pain. The end points are 0 = no pain and 10 = very much pain. The FPS-R scale was used for children over the age of 5 up to 12 years who have appropriate verbal skills.

Outcome measures

Outcome measures
Measure	All Patients A total of all 4 age groups: infant and toddler, young child, older child, and adolescent.	Oral ≥ 13 Months to < 5 Years n=21 Participants Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Oral ≥ 5 Years to < 12 Years n=26 Participants Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Oral ≥ 12 Years to < 17 Years Adolescent (Data for this group not collected. Test not appropriate for this age)
Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time Predose	—	1.50 units on a scale Standard Error 0.957	2.59 units on a scale Standard Error 0.446	—
Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time Dose 1 (1 hour postdose)	—	1.20 units on a scale Standard Error 1.200	2.25 units on a scale Standard Error 0.772	—
Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time Dose 2 (1 hour postdose)	—	1.33 units on a scale Standard Error 1.333	0.92 units on a scale Standard Error 0.431	—
Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time Dose 3 (1 hour postdose)	—	2.67 units on a scale Standard Error 0.667	1.54 units on a scale Standard Error 0.514	—
Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time Dose 4 (1 hour postdose)	—	0 units on a scale Standard Error 0	1.86 units on a scale Standard Error 0.710	—
Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time Dose 5 (1 hour postdose)	—	0 units on a scale Standard Error 0	1.64 units on a scale Standard Error 0.845	—
Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time Dose 6 (1 hour postdose)	—	0 units on a scale Standard Error 0	0.40 units on a scale Standard Error 0.400	—

SECONDARY outcome

Timeframe: Immediately prior to first oral dose, up to 54 hours

The Visual Analog Scale (VAS), a 10-cm Color Analog Scale anchored by the descriptors of 0 = "no pain" and 10 = "most pain," was used by children ≥ 12 years of age.

Outcome measures

Outcome measures
Measure	All Patients A total of all 4 age groups: infant and toddler, young child, older child, and adolescent.	Oral ≥ 13 Months to < 5 Years Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Oral ≥ 5 Years to < 12 Years Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Oral ≥ 12 Years to < 17 Years n=20 Participants Adolescent (Data for this group not collected. Test not appropriate for this age)
Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time Dose 3 (1 hour postdose)	—	—	—	4.09 unit on a scale Standard Error 0.569
Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time Predose	—	—	—	4.04 unit on a scale Standard Error 0.530
Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time Dose 1 (1 hour postdose)	—	—	—	3.73 unit on a scale Standard Error 0.629
Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time Dose 2 (1 hour postdose)	—	—	—	3.95 unit on a scale Standard Error 0.673
Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time Dose 4 (1 hour postdose)	—	—	—	4.13 unit on a scale Standard Error 0.599
Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time Dose 5 (1 hour postdose)	—	—	—	4.19 unit on a scale Standard Error 0.945
Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time Dose 6 (1 hour postdose)	—	—	—	3.25 unit on a scale Standard Error 0.998

Adverse Events

Oral ≥ 28 Days to < 13 Months

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Oral ≥ 13 Months to < 5 Years

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Oral ≥ 5 Years to <12 Years

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Oral ≥ 12 Years to < 17 Years

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Parenteral ≥ 28 Days to < 13 Months

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

Parenteral ≥ 13 Months to < 5 Years

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Parenteral ≥ 5 Years to < 12 Years

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Parenteral ≥ 12 Years to < 17 Years

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oral ≥ 28 Days to < 13 Months n=39 participants at risk Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Oral ≥ 13 Months to < 5 Years n=23 participants at risk Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Oral ≥ 5 Years to <12 Years n=29 participants at risk Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Oral ≥ 12 Years to < 17 Years n=25 participants at risk Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Parenteral ≥ 28 Days to < 13 Months n=39 participants at risk Infant and toddler - received parenteral analgesia up to 48 hours postsurgery.	Parenteral ≥ 13 Months to < 5 Years n=23 participants at risk Young child - received parenteral analgesia up to 48 hours postsurgery.	Parenteral ≥ 5 Years to < 12 Years n=29 participants at risk Older child - received parenteral analgesia up to 48 hours postsurgery.	Parenteral ≥ 12 Years to < 17 Years n=25 participants at risk Adolescent - received parenteral analgesia up to 48 hours postsurgery.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	3.4% 1/29 • Number of events 1 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Cardiac disorders Pericardial effusion - DEATH	2.6% 1/39 • Number of events 1 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Injury, poisoning and procedural complications Vascular procedure complication - DEATH	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	3.4% 1/29 • Number of events 1 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	8.7% 2/23 • Number of events 2 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	2.6% 1/39 • Number of events 1 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Infections and infestations Streptococcus pneumonia	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	2.6% 1/39 • Number of events 1 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	3.4% 1/29 • Number of events 1 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	2.6% 1/39 • Number of events 1 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	2.6% 1/39 • Number of events 1 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertensive crisis	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	2.6% 1/39 • Number of events 1 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Respiratory depression	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	2.6% 1/39 • Number of events 1 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Vascular disorders Hypovolaemic shock	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.0% 1/25 • Number of events 1 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.

Other adverse events

Other adverse events
Measure	Oral ≥ 28 Days to < 13 Months n=39 participants at risk Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Oral ≥ 13 Months to < 5 Years n=23 participants at risk Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Oral ≥ 5 Years to <12 Years n=29 participants at risk Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Oral ≥ 12 Years to < 17 Years n=25 participants at risk Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.	Parenteral ≥ 28 Days to < 13 Months n=39 participants at risk Infant and toddler - received parenteral analgesia up to 48 hours postsurgery.	Parenteral ≥ 13 Months to < 5 Years n=23 participants at risk Young child - received parenteral analgesia up to 48 hours postsurgery.	Parenteral ≥ 5 Years to < 12 Years n=29 participants at risk Older child - received parenteral analgesia up to 48 hours postsurgery.	Parenteral ≥ 12 Years to < 17 Years n=25 participants at risk Adolescent - received parenteral analgesia up to 48 hours postsurgery.
Gastrointestinal disorders Constipation	15.4% 6/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.3% 1/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	3.4% 1/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.0% 1/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.0% 1/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Gastrointestinal disorders Vomiting	5.1% 2/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	13.0% 3/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	3.4% 1/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	12.0% 3/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	8.7% 2/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	10.3% 3/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	16.0% 4/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
General disorders Oedema peripheral	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	8.0% 2/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	2.6% 1/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
General disorders Pyrexia	5.1% 2/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	13.0% 3/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	13.8% 4/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.0% 1/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	23.1% 9/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	26.1% 6/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	13.8% 4/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	20.0% 5/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Nervous system disorders Sedation	5.1% 2/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Nervous system disorders Somnolence	10.3% 4/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.3% 1/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	3.4% 1/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Renal and urinary disorders Urinary retention	2.6% 1/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	8.7% 2/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Atelectasis	2.6% 1/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	13.0% 3/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	6.9% 2/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	10.3% 4/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	13.0% 3/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	10.3% 3/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.0% 1/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Chylothorax	2.6% 1/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	8.7% 2/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.1% 2/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.3% 1/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	10.3% 3/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.0% 1/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	5.1% 2/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.3% 1/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	3.4% 1/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.6% 1/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.3% 1/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	13.8% 4/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.0% 1/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	5.1% 2/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.3% 1/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	2.6% 1/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	13.0% 3/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	3.4% 1/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	5.1% 2/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.3% 1/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	3.4% 1/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	8.7% 2/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Respiratory depression	30.8% 12/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	17.4% 4/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	8.0% 2/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	12.8% 5/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.3% 1/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Skin and subcutaneous tissue disorders Pruritus	7.7% 3/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	13.0% 3/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	13.8% 4/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.0% 1/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	25.6% 10/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	21.7% 5/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	20.7% 6/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	32.0% 8/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Blood and lymphatic system disorders Anaemia	2.6% 1/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	5.1% 2/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	8.7% 2/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	3.4% 1/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	12.0% 3/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Gastrointestinal disorders Nausea	5.1% 2/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.3% 1/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	6.9% 2/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.0% 1/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	2.6% 1/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	8.7% 2/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	13.8% 4/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	44.0% 11/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Investigations Urine output decreased	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	5.1% 2/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.0% 1/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Investigations Oxygen saturation decreased	2.6% 1/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.0% 1/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.3% 1/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	8.0% 2/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	8.7% 2/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	6.9% 2/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	12.8% 5/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	13.0% 3/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	5.1% 2/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.3% 1/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	6.9% 2/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	8.7% 2/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	3.4% 1/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.0% 1/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Nervous system disorders Dizziness	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.0% 1/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	8.0% 2/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Psychiatric disorders Agitation	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	5.1% 2/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	10.3% 3/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Psychiatric disorders Anxiety	2.6% 1/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.3% 1/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	3.4% 1/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.0% 1/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	28.2% 11/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	17.4% 4/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	6.9% 2/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Psychiatric disorders Restlessness	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.0% 1/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	8.0% 2/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	8.7% 2/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	20.5% 8/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	13.0% 3/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Vascular disorders Hypertension	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	4.3% 1/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	6.9% 2/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Vascular disorders Hypotension	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	6.9% 2/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	6.9% 2/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	7.7% 3/39 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/23 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	3.4% 1/29 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.	0.00% 0/25 • AEs that were ongoing or were reported during the 7 days following the subject's last dose of study drug were followed until resolution or for 30 days. SAEs were followed until the event resolved or the sequelae stabilized. Adverse events were learned of through spontaneous reports and subject interview. The duration of treatment was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Adverse events were collected for both parenteral and oral treatments.

Additional Information

Executive Medical Director

Purdue Pharma L.P.

Phone: 800-733-1333

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60