Trial Outcomes & Findings for Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI, and AD Subjects (NCT NCT02016560)

NCT ID: NCT02016560

Last Updated: 2020-09-22

Results Overview

Confirm the relationship between neocortical flortaucipir uptake and the subsequent rate of cognitive decline at longitudinal follow up that was observed in the Exploratory Phase of the study. Patients were assigned to groups by majority classification of the flortaucipir positron emission tomography (PET) scan by five independent imaging physicians. Clinically meaningful cognitive and functional deterioration was defined as a 1 point or greater worsening on clinical dementia rating - sum of boxes (CDR-SB) score over the follow-up period.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 383 participants
• Primary outcome timeframe: between baseline and 18 months
• Results posted on: 2020-09-22

Participant Flow

Exploratory cohort subjects were enrolled starting in Dec 2013. Confirmatory cohort subjects were enrolled Dec 2014-July 2017. Exploratory cohort subjects were not eligible for the confirmatory phase.

To ensure a distribution of disease severity in the confirmatory phase, a target was set to recruit at least one-third of the enrolled subjects with dementia

Participant milestones

Measure	Exploratory Young Cognitively Healthy Subjects Male or female subjects ≥20 to ≤40 years of age with mini-mental status exam (MMSE) score ≥29	Exploratory Older Cognitively Healthy Subjects Male or female subjects ≥50 years of age with MMSE Score ≥29	Exploratory MCI Subjects Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE Score ≥24	Exploratory AD Subjects Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE Score \>10	Confirmatory Subjects MCI Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27	Confirmatory Subjects AD Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27
Exploratory Phase STARTED	16	58	98	51	0	0
Exploratory Phase COMPLETED	16	54	62	35	0	0
Exploratory Phase NOT COMPLETED	0	4	36	16	0	0
Confirmatory Phase STARTED	0	0	0	0	98	62
Confirmatory Phase COMPLETED	0	0	0	0	76	35
Confirmatory Phase NOT COMPLETED	0	0	0	0	22	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age, Continuous for Exploratory Cohort only

Baseline characteristics by cohort

Measure	Exploratory Young Cognitively Healthy Subjects n=16 Participants Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29	Exploratory Older Cognitively Healthy Subjects n=58 Participants Male or female subjects ≥50 years of age with MMSE ≥29	Exploratory MCI Subjects n=98 Participants Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE ≥24	Exploratory AD Subjects n=51 Participants Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE \>10	Confirmatory Subjects MCI n=98 Participants Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27	Confirmatory Subjects AD n=62 Participants Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27	Total n=383 Participants Total of all reporting groups
Age, Continuous	28.9 years STANDARD_DEVIATION 4.88 • n=16 Participants • Age, Continuous for Exploratory Cohort only	68.5 years STANDARD_DEVIATION 10.29 • n=58 Participants • Age, Continuous for Exploratory Cohort only	70.8 years STANDARD_DEVIATION 9.3 • n=98 Participants • Age, Continuous for Exploratory Cohort only	73.9 years STANDARD_DEVIATION 9.01 • n=51 Participants • Age, Continuous for Exploratory Cohort only	72.5 years STANDARD_DEVIATION 9.69 • n=98 Participants • Age, Continuous for Confirmatory Cohort only	73.6 years STANDARD_DEVIATION 9.53 • n=62 Participants • Age, Continuous for Confirmatory Cohort only	72.9 years STANDARD_DEVIATION 9.61 • n=160 Participants • Age, Continuous for Confirmatory Cohort only
Sex: Female, Male Female	7 Participants n=16 Participants	26 Participants n=58 Participants	49 Participants n=98 Participants	28 Participants n=51 Participants	44 Participants n=98 Participants	30 Participants n=62 Participants	184 Participants n=383 Participants
Sex: Female, Male Male	9 Participants n=16 Participants	32 Participants n=58 Participants	49 Participants n=98 Participants	23 Participants n=51 Participants	54 Participants n=98 Participants	32 Participants n=62 Participants	199 Participants n=383 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=16 Participants	1 Participants n=58 Participants	4 Participants n=98 Participants	0 Participants n=51 Participants	5 Participants n=98 Participants	4 Participants n=62 Participants	15 Participants n=383 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=16 Participants	57 Participants n=58 Participants	94 Participants n=98 Participants	51 Participants n=51 Participants	93 Participants n=98 Participants	58 Participants n=62 Participants	368 Participants n=383 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=16 Participants	0 Participants n=58 Participants	0 Participants n=98 Participants	0 Participants n=51 Participants	0 Participants n=98 Participants	0 Participants n=62 Participants	0 Participants n=383 Participants
Race/Ethnicity, Customized Asian	1 Participants n=16 Participants	1 Participants n=58 Participants	1 Participants n=98 Participants	0 Participants n=51 Participants	1 Participants n=98 Participants	1 Participants n=62 Participants	5 Participants n=383 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=16 Participants	9 Participants n=58 Participants	7 Participants n=98 Participants	2 Participants n=51 Participants	3 Participants n=98 Participants	0 Participants n=62 Participants	24 Participants n=383 Participants
Race/Ethnicity, Customized White	11 Participants n=16 Participants	47 Participants n=58 Participants	89 Participants n=98 Participants	47 Participants n=51 Participants	94 Participants n=98 Participants	61 Participants n=62 Participants	349 Participants n=383 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=16 Participants	0 Participants n=58 Participants	0 Participants n=98 Participants	1 Participants n=51 Participants	0 Participants n=98 Participants	0 Participants n=62 Participants	1 Participants n=383 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=16 Participants	0 Participants n=58 Participants	0 Participants n=98 Participants	0 Participants n=51 Participants	0 Participants n=98 Participants	0 Participants n=62 Participants	0 Participants n=383 Participants
Race/Ethnicity, Customized Other	1 Participants n=16 Participants	1 Participants n=58 Participants	1 Participants n=98 Participants	1 Participants n=51 Participants	0 Participants n=98 Participants	0 Participants n=62 Participants	4 Participants n=383 Participants
Clinical Dementia Rating - Sum of Boxes (CDR-SB)	—	—	—	—	2.8 units on a scale STANDARD_DEVIATION 1.73 • n=98 Participants • Recorded at baseline only for confirmatory phase subjects	4.3 units on a scale STANDARD_DEVIATION 1.69 • n=61 Participants • Recorded at baseline only for confirmatory phase subjects	3.4 units on a scale STANDARD_DEVIATION 1.88 • n=159 Participants • Recorded at baseline only for confirmatory phase subjects

PRIMARY outcome

Timeframe: between baseline and 18 months

Population: Subjects from the confirmatory phase with valid flortaucipir visual read and 9 or 18 month clinical follow-up.

Confirm the relationship between neocortical flortaucipir uptake and the subsequent rate of cognitive decline at longitudinal follow up that was observed in the Exploratory Phase of the study. Patients were assigned to groups by majority classification of the flortaucipir positron emission tomography (PET) scan by five independent imaging physicians. Clinically meaningful cognitive and functional deterioration was defined as a 1 point or greater worsening on clinical dementia rating - sum of boxes (CDR-SB) score over the follow-up period.

Outcome measures

Measure	Predicted to Progress n=63 Participants Subjects with an Advanced AD Scan Pattern (τAD++). In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the PLT, parietal, or occipital region(s).	Not Predicted to Progress n=68 Participants Subjects with a Moderate AD Scan Pattern (τAD+) or Not AD Scan Pattern (τAD-). Moderate scans were defined as in either hemisphere, increased neocortical activity limited to the posterolateral temporal (PLT) or occipital region(s). Not AD scans were defined as no increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.	Exploratory Older Cognitively Healthy Subjects Male or female subjects ≥50 years of age with MMSE ≥29	Exploratory Young Cognitively Healthy Subjects Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29	Exploratory Older Cognitively Healthy Subjects >=80 Male or female subjects 80 years of age or older with MMSE ≥29
Confirmatory Phase: Relationship Between Neocortical Flortaucipir Uptake and the Subsequent Rate of Cognitive Decline Clinically meaningful progression	36 Participants	31 Participants	—	—	—
Confirmatory Phase: Relationship Between Neocortical Flortaucipir Uptake and the Subsequent Rate of Cognitive Decline Did Not Progress	27 Participants	37 Participants	—	—	—

PRIMARY outcome

Timeframe: baseline scan

Population: Analysis included all subjects who received an injection of flortaucipir, had valid quantifiable flortaucipir imaging data available, and valid quantifiable florbetapir PET data.

Flortaucipir standardized uptake value ratio (SUVr). A value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

Outcome measures

Measure	Predicted to Progress n=48 Participants Subjects with an Advanced AD Scan Pattern (τAD++). In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the PLT, parietal, or occipital region(s).	Not Predicted to Progress n=97 Participants Subjects with a Moderate AD Scan Pattern (τAD+) or Not AD Scan Pattern (τAD-). Moderate scans were defined as in either hemisphere, increased neocortical activity limited to the posterolateral temporal (PLT) or occipital region(s). Not AD scans were defined as no increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.	Exploratory Older Cognitively Healthy Subjects n=57 Participants Male or female subjects ≥50 years of age with MMSE ≥29	Exploratory Young Cognitively Healthy Subjects n=16 Participants Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29	Exploratory Older Cognitively Healthy Subjects >=80 Male or female subjects 80 years of age or older with MMSE ≥29
Exploratory Phase: Cross-sectional Flortaucipir Imaging Results Aβ+ SUVr	1.53 standardized uptake value ratio (SUVr) Standard Error 0.037	1.26 standardized uptake value ratio (SUVr) Standard Error 0.030	1.08 standardized uptake value ratio (SUVr) Standard Error 0.093	—	—
Exploratory Phase: Cross-sectional Flortaucipir Imaging Results Aβ- SUVr	1.03 standardized uptake value ratio (SUVr) Standard Error 0.051	0.99 standardized uptake value ratio (SUVr) Standard Error 0.029	0.98 standardized uptake value ratio (SUVr) Standard Error 0.029	1.01 standardized uptake value ratio (SUVr) Standard Error 0.039	—

PRIMARY outcome

Timeframe: baseline and 18 months

Population: Analysis of flortaucipir SUVr Change Over Time by Amyloid Status, Exploratory Phase Efficacy Population (AD and MCI subjects only)

Assess the rate of change of tau deposition as measured by flortaucipir uptake (SUVr) over time. Change = 18 months SUVr - baseline SUVr.

Outcome measures

Measure	Predicted to Progress n=55 Participants Subjects with an Advanced AD Scan Pattern (τAD++). In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the PLT, parietal, or occipital region(s).	Not Predicted to Progress n=90 Participants Subjects with a Moderate AD Scan Pattern (τAD+) or Not AD Scan Pattern (τAD-). Moderate scans were defined as in either hemisphere, increased neocortical activity limited to the posterolateral temporal (PLT) or occipital region(s). Not AD scans were defined as no increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.	Exploratory Older Cognitively Healthy Subjects Male or female subjects ≥50 years of age with MMSE ≥29	Exploratory Young Cognitively Healthy Subjects Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29	Exploratory Older Cognitively Healthy Subjects >=80 Male or female subjects 80 years of age or older with MMSE ≥29
Exploratory Phase: Longitudinal Change in Tau Deposition Over Time, by Amyloid Status	0.052359 standardized uptake value ratio (SUVr) Standard Error 0.008536	0.000655 standardized uptake value ratio (SUVr) Standard Error 0.002394	—	—	—

SECONDARY outcome

Timeframe: baseline and 18 months

Population: All confirmatory phase subjects who completed 18 months of follow-up for the cognitive endpoint were read by each reader

This analysis used dichotomized CDR-SB change as a truth standard (1 point or more worsening = true positive vs. less than 1 point worsening = true negative) to assess the diagnostic performance of baseline Advanced AD tau status (τAD++) as determined by flortaucipir scan interpretation. Sensitivity and Specificity were calculated for each of the 5 independent imaging readers. Sensitivity is the percentage of true positive cases correctly identified by an Advanced AD pattern scan. Specificity is the percentage of true negative cases correctly identified by scans that were not classified as Advanced AD pattern.

Outcome measures

Measure	Predicted to Progress n=110 Participants Subjects with an Advanced AD Scan Pattern (τAD++). In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the PLT, parietal, or occipital region(s).	Not Predicted to Progress Subjects with a Moderate AD Scan Pattern (τAD+) or Not AD Scan Pattern (τAD-). Moderate scans were defined as in either hemisphere, increased neocortical activity limited to the posterolateral temporal (PLT) or occipital region(s). Not AD scans were defined as no increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.	Exploratory Older Cognitively Healthy Subjects Male or female subjects ≥50 years of age with MMSE ≥29	Exploratory Young Cognitively Healthy Subjects Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29	Exploratory Older Cognitively Healthy Subjects >=80 Male or female subjects 80 years of age or older with MMSE ≥29
Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read Reader 1 Sensitivity	59.6 percentage of cases correctly identified Interval 46.1 to 71.8	—	—	—	—
Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read Reader 5 Specificity	65.5 percentage of cases correctly identified Interval 52.7 to 76.4	—	—	—	—
Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read Reader 1 Specificity	65.5 percentage of cases correctly identified Interval 52.7 to 76.4	—	—	—	—
Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read Reader 2 Sensitivity	53.8 percentage of cases correctly identified Interval 40.5 to 66.7	—	—	—	—
Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read Reader 2 Specificity	65.5 percentage of cases correctly identified Interval 52.7 to 76.4	—	—	—	—
Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read Reader 3 Sensitivity	55.8 percentage of cases correctly identified Interval 42.3 to 68.4	—	—	—	—
Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read Reader 3 Specificity	65.5 percentage of cases correctly identified Interval 52.7 to 76.4	—	—	—	—
Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read Reader 4 Sensitivity	59.6 percentage of cases correctly identified Interval 46.1 to 71.8	—	—	—	—
Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read Reader 4 Specificity	65.5 percentage of cases correctly identified Interval 52.7 to 76.4	—	—	—	—
Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read Reader 5 Sensitivity	50.0 percentage of cases correctly identified Interval 36.9 to 63.1	—	—	—	—

SECONDARY outcome

Timeframe: baseline scan

Population: Exploratory Young and Old healthy control subjects with a valid flortaucipir PET scan

Flortaucipir standardized uptake value ratio (SUVr). A value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

Outcome measures

Measure	Predicted to Progress n=16 Participants Subjects with an Advanced AD Scan Pattern (τAD++). In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the PLT, parietal, or occipital region(s).	Not Predicted to Progress n=15 Participants Subjects with a Moderate AD Scan Pattern (τAD+) or Not AD Scan Pattern (τAD-). Moderate scans were defined as in either hemisphere, increased neocortical activity limited to the posterolateral temporal (PLT) or occipital region(s). Not AD scans were defined as no increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.	Exploratory Older Cognitively Healthy Subjects n=15 Participants Male or female subjects ≥50 years of age with MMSE ≥29	Exploratory Young Cognitively Healthy Subjects n=16 Participants Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29	Exploratory Older Cognitively Healthy Subjects >=80 n=11 Participants Male or female subjects 80 years of age or older with MMSE ≥29
Exploratory Phase: Correlation Between Flortaucipir SUVr and Age	1.0083 standardized uptake value ratio (SUVr) Standard Deviation 0.03905	1.0203 standardized uptake value ratio (SUVr) Standard Deviation 0.03693	1.0110 standardized uptake value ratio (SUVr) Standard Deviation 0.04149	1.0010 standardized uptake value ratio (SUVr) Standard Deviation 0.02604	1.0048 standardized uptake value ratio (SUVr) Standard Deviation 0.03978

Adverse Events

Exploratory Younger Cognitively Healthy Subjects

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Exploratory Older Cognitively Healthy Subjects

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Exploratory MCI Subjects

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Exploratory AD Subjects

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Confirmatory Subjects MCI

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Confirmatory Subjects AD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Exploratory Younger Cognitively Healthy Subjects n=16 participants at risk Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29	Exploratory Older Cognitively Healthy Subjects n=58 participants at risk Male or female subjects ≥50 years of age with MMSE ≥29	Exploratory MCI Subjects n=98 participants at risk Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE ≥24	Exploratory AD Subjects n=51 participants at risk Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE \>10	Confirmatory Subjects MCI n=98 participants at risk Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27	Confirmatory Subjects AD n=62 participants at risk Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27
Cardiac disorders angina pectoris	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.

Other adverse events

Measure	Exploratory Younger Cognitively Healthy Subjects n=16 participants at risk Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29	Exploratory Older Cognitively Healthy Subjects n=58 participants at risk Male or female subjects ≥50 years of age with MMSE ≥29	Exploratory MCI Subjects n=98 participants at risk Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE ≥24	Exploratory AD Subjects n=51 participants at risk Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE \>10	Confirmatory Subjects MCI n=98 participants at risk Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27	Confirmatory Subjects AD n=62 participants at risk Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27
Cardiac disorders Angina pectoris	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.7% 1/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	2.0% 2/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Cardiac disorders Bradycardia	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.7% 1/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Eye disorders Ocular hyperaemia	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Gastrointestinal disorders Abdominal pain	6.2% 1/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Gastrointestinal disorders Flatulence	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.7% 1/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Gastrointestinal disorders Frequent bowel movements	6.2% 1/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Gastrointestinal disorders Vomiting	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	2.0% 1/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
General disorders Injection site pain	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	8.6% 5/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	8.2% 8/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	3.9% 2/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	6.1% 6/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
General disorders Injection site extravasation	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	3.1% 3/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	2.0% 1/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
General disorders Fatigue	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	3.4% 2/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
General disorders Application site irritation	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.7% 1/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
General disorders Application site laceration	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	2.0% 1/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
General disorders Feeling abnormal	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
General disorders Therapeutic response unexpected	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	2.0% 1/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Investigations Blood pressure increased	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	3.4% 2/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	2.0% 2/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	2.0% 1/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Investigations Blood pressure systolic increased	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	3.4% 2/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	2.0% 1/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Investigations Platelet count decreased	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	2.0% 1/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Investigations Heart rate increased	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.7% 1/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	2.0% 1/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Nervous system disorders Headache	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	5.2% 3/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	3.1% 3/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	2.0% 1/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	4.1% 4/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Nervous system disorders Paraesthesia	6.2% 1/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Nervous system disorders Amnesia	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Nervous system disorders Disturbance in attention	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.7% 1/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Nervous system disorders Dizziness	6.2% 1/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	2.0% 2/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Nervous system disorders Head discomfort	6.2% 1/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Nervous system disorders Hypoaesthesia	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Nervous system disorders Memory impairment	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Nervous system disorders Somnolence	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	2.0% 1/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Renal and urinary disorders Urinary incontinence	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.7% 1/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	2.0% 1/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.7% 1/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Vascular disorders Hypertension	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.7% 1/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	3.9% 2/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Vascular disorders Hot flush	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Eye disorders Cyanopsia	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Eye disorders Eye irritation	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Psychiatric disorders Panic attack	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/16 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/58 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/51 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	1.0% 1/98 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.	0.00% 0/62 • Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.

Additional Information

Medical Director

Avid Radiopharmaceuticals, Inc.

Phone: 215-298-0700

Email: clinicaloperations@avidrp.com

Results disclosure agreements

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

Restriction type: LTE60