Trial Outcomes & Findings for A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression (NCT NCT02614547)

Last Updated: 2025-09-15

Results Overview

The HAM-D total score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, and higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Baseline, 60 Hours

Results posted on

2025-09-15

Participant Flow

Participants took part in the study at 4 centers in the United States from 15 December 2015 to 22 June 2016.

A total of 21 participants were randomized into the study to receive either placebo or SAGE-547.

Participant milestones

Participant milestones
Measure	Placebo Participants received infusion rates of placebo matched to SAGE-547.	SAGE-547 Participants received a 4-hour dose titration period of 30 micrograms per kilogram per hour (micrograms/kg/hr) (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
Overall Study STARTED	11	10
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=11 Participants Participants received infusion rates of placebo matched to SAGE-547.	SAGE-547 n=10 Participants Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).	Total n=21 Participants Total of all reporting groups
Age, Continuous	28.8 years STANDARD_DEVIATION 4.58 • n=5 Participants	27.4 years STANDARD_DEVIATION 5.34 • n=7 Participants	28.1 years STANDARD_DEVIATION 4.88 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 60 Hours

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants received infusion rates of placebo matched to SAGE-547.	SAGE-547 n=10 Participants Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
Change From Baseline at End of Treatment Period (at 60 Hours) in Hamilton Rating Scale for Depression (HAM-D) Total Score	-8.75 score on a scale Standard Error 2.800	-20.97 score on a scale Standard Error 2.938

SECONDARY outcome

Timeframe: 60 Hours, Days 7 and 30

Population: Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.

The HAM-D response was defined as having a 50 percent (%) or greater reduction from baseline in HAM-D total score. The HAM-D total score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, and higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants received infusion rates of placebo matched to SAGE-547.	SAGE-547 n=10 Participants Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
Percentage of Participants With HAM-D Response 60 Hours	36.4 percentage of participants	70.0 percentage of participants
Percentage of Participants With HAM-D Response Day 7	20.0 percentage of participants	80.0 percentage of participants
Percentage of Participants With HAM-D Response Day 30	27.3 percentage of participants	70.0 percentage of participants

SECONDARY outcome

Timeframe: 60 Hours, Days 7, and 30

Population: Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed'' signifies participants evaluable for this outcome measure at specified time points.

The HAM-D remission was defined as having a HAM-D total score of less than or equal to (\<=)7. The HAM-D total score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, and higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants received infusion rates of placebo matched to SAGE-547.	SAGE-547 n=10 Participants Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
Percentage of Participants With HAM-D Remission 60 Hours	9.1 percentage of participants	70.0 percentage of participants
Percentage of Participants With HAM-D Remission Day 7	0.0 percentage of participants	70.0 percentage of participants
Percentage of Participants With HAM-D Remission Day 30	18.2 percentage of participants	70.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 60 Hours, Days 7 and 30

Population: Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed'' signifies participants evaluable for this outcome measure at specified time points.

The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicate more severe depression. A negative change from baseline indicate less severe depression. A positive change from baseline indicates more severe depression.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants received infusion rates of placebo matched to SAGE-547.	SAGE-547 n=10 Participants Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Hour 60	-12.10 score on a scale Standard Error 3.817	-27.96 score on a scale Standard Error 4.001
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Day 7	-11.60 score on a scale Standard Error 3.766	-27.56 score on a scale Standard Error 3.929
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Day 30	-11.19 score on a scale Standard Error 3.594	-26.26 score on a scale Standard Error 3.767

SECONDARY outcome

Timeframe: 60 Hours, Days 7 and 30

Population: Efficacy population included the subset of the all randomized participants who started the study drug infusion and who had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Here, 'number analyzed'' signifies participants evaluable for this outcome measure at specified time points.

The CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments, and by definition, was evaluated against baseline conditions. CGI-I response was defined as having a CGI-I score of "very much improved" or "much improved".

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants received infusion rates of placebo matched to SAGE-547.	SAGE-547 n=10 Participants Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Response Day 30	27.3 percentage of participants	80.0 percentage of participants
Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Response Hour 60	36.4 percentage of participants	80.0 percentage of participants
Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Response Day 7	20.0 percentage of participants	80.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, 60 Hours, Days 7 and 30

The HAM-D Bech 6 subscale score was calculated as the sum of the following six items: depressed mood, feelings of guilt, work and activities, retardation, psychic anxiety, and general somatic symptoms. Each item is scored in a range of 0 to 2 or 0 to 4, with higher scores indicating a greater degree of depression. The scores were transformed to a scale of 0 to 100, with a higher score indicating a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants received infusion rates of placebo matched to SAGE-547.	SAGE-547 n=10 Participants Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
Change From Baseline in HAM-D Bech 6 Subscale 60 Hours	-4.89 score on a scale Standard Error 1.701	-10.94 score on a scale Standard Error 1.784
Change From Baseline in HAM-D Bech 6 Subscale Day 7	-3.99 score on a scale Standard Error 1.676	-10.44 score on a scale Standard Error 1.754
Change From Baseline in HAM-D Bech 6 Subscale Day 30	-3.34 score on a scale Standard Error 1.772	-10.14 score on a scale Standard Error 1.858

SECONDARY outcome

Timeframe: Baseline, 60 Hours

The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants received infusion rates of placebo matched to SAGE-547.	SAGE-547 n=10 Participants Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Depressed Mood, Change From Baseline to 60 Hours	-1.4 score on a scale Standard Deviation 1.57	-2.5 score on a scale Standard Deviation 1.58
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Feeling of Guilt ,Change From Baseline to 60 Hours	-0.5 score on a scale Standard Deviation 0.69	-1.7 score on a scale Standard Deviation 0.95
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Suicide, Change From Baseline to 60 Hours	-0.4 score on a scale Standard Deviation 0.67	-1.1 score on a scale Standard Deviation 0.88
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Insomnia - Early, Change From Baseline to 60 Hours	-0.5 score on a scale Standard Deviation 0.69	-1.6 score on a scale Standard Deviation 0.70
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Insomnia -Middle, Change From Baseline to 60 Hours	-0.5 score on a scale Standard Deviation 0.69	-1.6 score on a scale Standard Deviation 0.52
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Insomnia - Late, Change From Baseline to 60 Hours	-0.4 score on a scale Standard Deviation 0.50	-1.1 score on a scale Standard Deviation 0.74
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Work and Activities, Change From Baseline to 60 Hours	-1.4 score on a scale Standard Deviation 1.36	-2.4 score on a scale Standard Deviation 1.35
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Retardation, Change From Baseline to 60 Hours	-0.5 score on a scale Standard Deviation 0.69	-0.8 score on a scale Standard Deviation 0.79
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Agitation, Change From Baseline to 60 Hours	-0.3 score on a scale Standard Deviation 0.65	-0.3 score on a scale Standard Deviation 0.67
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Anxiety-Psychic, Change From Baseline to 60 Hours	-0.9 score on a scale Standard Deviation 1.30	-1.9 score on a scale Standard Deviation 1.29
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Anxiety-Somatic, Change From Baseline to 60 Hours	-1.0 score on a scale Standard Deviation 1.10	-1.9 score on a scale Standard Deviation 1.66
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Gastrointestinal, Change From Baseline to 60 Hours	-0.4 score on a scale Standard Deviation 0.81	-0.7 score on a scale Standard Deviation 0.95
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Somatic General, Change From Baseline to 60 Hours	-0.4 score on a scale Standard Deviation 0.67	-1.5 score on a scale Standard Deviation 0.85
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Genital Symptoms, Change From Baseline to 60 Hours	-0.2 score on a scale Standard Deviation 0.60	-0.8 score on a scale Standard Deviation 0.79
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Hypochondriasis, Change From Baseline to 60 Hours	-0.3 score on a scale Standard Deviation 1.19	-0.5 score on a scale Standard Deviation 0.71
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Loss of Weight, Change From Baseline to 60 Hours	-0.4 score on a scale Standard Deviation 0.67	-0.2 score on a scale Standard Deviation 0.67
Change From Baseline to 60 Hours in the HAM-D Individual Item Scores Insight, Change From Baseline to 60 Hours	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline, 60 Hours, Day 7 and 30

The GAD-7 is a participant-rated, generalized anxiety symptom severity scale. Scoring for GAD-7 generalized anxiety is calculated by assigning scores of 0 = "not at all sure," 1 = "several days," 2 = "over half the days," and 3 = "nearly every day" to the response categories. The GAD-7 total score for the seven items ranges from 0 to 21, where a score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and 15 to 21 = severe anxiety. The GAD-7 total score was calculated as the sum of the seven individual item scores. A negative change from baseline indicates less anxiety. A positive change from baseline indicates more anxiety.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants received infusion rates of placebo matched to SAGE-547.	SAGE-547 n=10 Participants Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
Change From Baseline in Generalized Anxiety Disorder 7-item Scale (GAD-7) Total Score 60 Hours	-9.08 score on a scale Standard Error 1.673	-7.21 score on a scale Standard Error 1.757
Change From Baseline in Generalized Anxiety Disorder 7-item Scale (GAD-7) Total Score Day 7	-7.96 score on a scale Standard Error 1.986	-9.44 score on a scale Standard Error 1.986
Change From Baseline in Generalized Anxiety Disorder 7-item Scale (GAD-7) Total Score Day 30	-7.38 score on a scale Standard Error 1.951	-9.48 score on a scale Standard Error 2.050

SECONDARY outcome

Timeframe: Up to 30 days

Population: Safety population included all randomized participants who started the study drug infusion.

An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants Participants received infusion rates of placebo matched to SAGE-547.	SAGE-547 n=10 Participants Participants received a 4-hour dose titration period of 30 micrograms/kg/hr (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	8 Participants	4 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

SAGE-547

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Medical Monitor

Sage Therapeutics

Phone: (617) 299-8380

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=11 participants at risk Participants received infusion rates of placebo matched to SAGE-547.	SAGE-547 n=10 participants at risk Participants received a 4-hour dose titration period of 30 microgram per kilogram per hour (microgram/kg/hr) (0 to 4 hours), then 60 microgram/kg/hr (4 to 24 hours), then 90 microgram/kg/hr (24 to 52 hours), followed by a taper to 60 microgram/kg/hr (52 to 56 hours), and 30 microgram/kg/hr (56 to 60 hours).
Nervous system disorders Dizziness	27.3% 3/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	20.0% 2/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Nervous system disorders Somnolence	0.00% 0/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	20.0% 2/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Nervous system disorders Dizziness postural	0.00% 0/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	10.0% 1/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Nervous system disorders Sedation	0.00% 0/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	10.0% 1/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Psychiatric disorders Abnormal dreams	18.2% 2/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	0.00% 0/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Nervous system disorders Headache	18.2% 2/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	0.00% 0/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Psychiatric disorders Insomnia	18.2% 2/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	0.00% 0/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Psychiatric disorders Anxiety	9.1% 1/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	0.00% 0/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Nervous system disorders Tension headache	9.1% 1/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	0.00% 0/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Cardiac disorders Sinus Tachycardia	0.00% 0/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	10.0% 1/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Ear and labyrinth disorders Vertigo	0.00% 0/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	10.0% 1/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Gastrointestinal disorders Abdominal Pain	9.1% 1/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	0.00% 0/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Gastrointestinal disorders Dry Mouth	0.00% 0/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	10.0% 1/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Gastrointestinal disorders Nausea	27.3% 3/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	10.0% 1/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
General disorders Infusion Site Extravasation	9.1% 1/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	0.00% 0/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
General disorders Infusion Site Pain	18.2% 2/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	0.00% 0/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
General disorders Localised Odema	9.1% 1/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	0.00% 0/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
General disorders Pyrexia	0.00% 0/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	10.0% 1/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Injury, poisoning and procedural complications Skin Abrasion	9.1% 1/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	0.00% 0/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Musculoskeletal and connective tissue disorders Pain In Extremity	9.1% 1/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	0.00% 0/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Skin and subcutaneous tissue disorders Rash	9.1% 1/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	10.0% 1/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.
Vascular disorders Hot Flush	0.00% 0/11 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.	10.0% 1/10 • Up to 30 days Safety population included all randomized participants who started the study drug infusion.