Trial Outcomes & Findings for Study of Diagnostic Performance of [18F]CTT1057 in BCR (NCT NCT04838613)

Last Updated: 2025-10-20

Results Overview

Region-level correct localization rate (CLR) is defined as the percentage of regions containing at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings within the same region, out of all regions containing at least one PET-positive finding.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

190 participants

Primary outcome timeframe

vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)

Results posted on

2025-10-20

Participant Flow

190 participants were randomized using a 1:1 ratio to receive either Sequence 1 (vidoflufolastat (18F) followed by gallium (68Ga) gozetotide; N= 96) or Sequence 2 (gallium (68Ga) gozetotide followed by vidoflufolastat (18F); N=94). Out of the 190 randomized participants, 169 completed the study.

Prior to participation in the study, patients had to have biopsy proven prostate adenocarcinoma and diagnosis of biochemical recurrence following initial definitive therapy with either radical prostatectomy or curative intent radiation therapy.

Participant milestones

Participant milestones
Measure	PET/CT Imaging With Vidoflufolastat (18F) Followed by Gallium (68Ga) Gozetotide: Sequence 1 All eligible participants were assigned to this PET/CT scan sequence at random in a 1:1 ratio: \- Sequence 1: vidoflufolastat (18F) on Day 1 (investigational imaging agent of interest) followed by gallium (68Ga) gozetotide at least 14 days apart (as part of CTS if required, and for secondary endpoint)	PET/CT Imaging With Gallium (68Ga) Gozetotide Followed by Vidoflufolastat (18F): Sequence 2 All eligible participants were assigned to the following PET/CT scan sequence at random in a 1:1 ratio: \- Sequence 2: gallium (68Ga) gozetotide (as part of CTS if required, and for secondary endpoint) on Day 1 followed by vidoflufolastat (18F) (investigational imaging agent of interest) at least 14 days apart
Overall Study STARTED	96	94
Overall Study COMPLETED	88	81
Overall Study NOT COMPLETED	8	13

Reasons for withdrawal

Reasons for withdrawal
Measure	PET/CT Imaging With Vidoflufolastat (18F) Followed by Gallium (68Ga) Gozetotide: Sequence 1 All eligible participants were assigned to this PET/CT scan sequence at random in a 1:1 ratio: \- Sequence 1: vidoflufolastat (18F) on Day 1 (investigational imaging agent of interest) followed by gallium (68Ga) gozetotide at least 14 days apart (as part of CTS if required, and for secondary endpoint)	PET/CT Imaging With Gallium (68Ga) Gozetotide Followed by Vidoflufolastat (18F): Sequence 2 All eligible participants were assigned to the following PET/CT scan sequence at random in a 1:1 ratio: \- Sequence 2: gallium (68Ga) gozetotide (as part of CTS if required, and for secondary endpoint) on Day 1 followed by vidoflufolastat (18F) (investigational imaging agent of interest) at least 14 days apart
Overall Study Withdrawal by Subject	3	6
Overall Study Protocol Deviation	3	2
Overall Study Technical Problems	0	5
Overall Study Physician Decision	2	0

Baseline Characteristics

Study of Diagnostic Performance of [18F]CTT1057 in BCR

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PET/CT Imaging With Vidoflufolastat (18F) Followed by Gallium (68Ga) Gozetotide or Vice Versa n=190 Participants All eligible participants were assigned to one of the following two PET/CT scan sequences at random in a 1:1 ratio:- Sequence 1: vidoflufolastat (18F) on Day 1 (investigational imaging agent of interest) followed by gallium (68Ga) gozetotide at least 14 days apart (as part of CTS if required, and for secondary endpoint)- Sequence 2: gallium (68Ga) gozetotide (as part of CTS if required, and for secondary endpoint) on Day 1 followed by vidoflufolastat (18F) (investigational imaging agent of interest) at least 14 days apart
Age, Continuous	67.2 Years STANDARD_DEVIATION 7.83 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	190 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants
Race/Ethnicity, Customized White	180 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: vidoflufolastat (18F) PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)

Population: The Efficacy Analysis Set (EFF) included all randomized participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan imaging and at least one evaluable CTS assessment, and did not receive any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures. Baseline PSA levels were unavailable for 4 of the 161 participants in the EFF set.

Outcome measures

Outcome measures
Measure	Central Reader 1 n=161 Participants Central Reading Center 1	Central Reader 2 n=161 Participants Central Reading Center 2	Central Reader 3 n=161 Participants Central Reading Center 3
Region-level Correct Localization Rate (CLR) of Vidoflufolastat (18F)	75.0 Percentage of regions Interval 62.1 to 84.6	68.9 Percentage of regions Interval 55.43 to 79.73	65.2 Percentage of regions Interval 53.4 to 75.38

PRIMARY outcome

Patient-level positive predictive value (PPV) is defined as the percentage of participants who have at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all participants who are PET/CT scan positive.

Outcome measures

Outcome measures
Measure	Central Reader 1 n=161 Participants Central Reading Center 1	Central Reader 2 n=161 Participants Central Reading Center 2	Central Reader 3 n=161 Participants Central Reading Center 3
Patient-level Positive Predictive Value (PPV) (With Anatomical Localization) of Vidoflufolastat (18F)	76.5 Percentage of participants Interval 62.51 to 87.21	69.0 Percentage of participants Interval 55.46 to 80.46	64.6 Percentage of participants Interval 51.77 to 76.08

SECONDARY outcome

Patient-level sensitivity is defined as the percentage of participants who test positive on vidoflufolastat (18F) and Composite Truth Standard (CTS) (True Positive (TP)) among those that are CTS positive (True Positive (TP) or False Negative (FN)).

Outcome measures

Outcome measures
Measure	Central Reader 1 n=161 Participants Central Reading Center 1	Central Reader 2 n=161 Participants Central Reading Center 2	Central Reader 3 n=161 Participants Central Reading Center 3
Patient-level Sensitivity of Vidoflufolastat (18F)	63.9 Percentage of participants Interval 50.63 to 75.84	66.7 Percentage of participants Interval 53.31 to 78.31	71.2 Percentage of participants Interval 57.92 to 82.24

SECONDARY outcome

Population: The Efficacy Analysis Set (EFF) included all enrolled participants who received the dose of investigational treatment (i.e. vidoflufolastat (18F)), had both an evaluable vidoflufolastat (18F) PET/CT scan and at least one evaluable CTS assessment, and did not receive any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery. Baseline PSA levels were unavailable for 4 of the 161 participants in the EFF set.

Patient-level specificity is defined as the percentage of participants who test negative on vidoflufolastat (18F) and CTS (True Negative (TN)) among those that are CTS negative (True Negative (TN) or False Positive (FP)).

Outcome measures

Outcome measures
Measure	Central Reader 1 n=161 Participants Central Reading Center 1	Central Reader 2 n=161 Participants Central Reading Center 2	Central Reader 3 n=161 Participants Central Reading Center 3
Patient-level Specificity of Vidoflufolastat (18F)	88.0 Percentage of participants Interval 79.98 to 93.64	82.2 Percentage of participants Interval 73.3 to 89.08	77.5 Percentage of participants Interval 68.11 to 85.14

SECONDARY outcome

Patient-level negative predictive value is defined as the percentage of participants who are both vidoflufolastat (18F) and CTS negative (True Negative (TN)) among those who test negative on vidoflufolastat (18F) (True Negative (TN) or False Negative (FN)).

Outcome measures

Outcome measures
Measure	Central Reader 1 n=161 Participants Central Reading Center 1	Central Reader 2 n=161 Participants Central Reading Center 2	Central Reader 3 n=161 Participants Central Reading Center 3
Patient-level Negative Predictive Value (NPV) of Vidoflufolastat (18F)	80.0 Percentage of participants Interval 71.3 to 87.02	80.6 Percentage of participants Interval 71.62 to 87.72	82.3 Percentage of participants Interval 73.17 to 89.33

SECONDARY outcome

Patient-level accuracy is defined as the percentage of participants who are CTS and vidoflufolastat (18F) positive (True Positive (TP)) and negative (True Negative (TN)) among those participants that identified on vidoflufolastat (18F) (True Positive (TP), True Negative (TN), False Positive (FP) or False Negative (FN)).

Outcome measures

Outcome measures
Measure	Central Reader 1 n=161 Participants Central Reading Center 1	Central Reader 2 n=161 Participants Central Reading Center 2	Central Reader 3 n=161 Participants Central Reading Center 3
Patient-level Accuracy of Vidoflufolastat (18F)	78.9 Percentage of participants Interval 71.76 to 84.91	76.4 Percentage of participants Interval 69.07 to 82.72	75.2 Percentage of participants Interval 67.74 to 81.62

SECONDARY outcome

Patient-level correct detection rate (CDR) is defined as the percentage of participants who have at least one True Positive (TP) lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all participants who are scanned.

Outcome measures

Outcome measures
Measure	Central Reader 1 n=161 Participants Central Reading Center 1	Central Reader 2 n=161 Participants Central Reading Center 2	Central Reader 3 n=161 Participants Central Reading Center 3
Patient-level Correct Detection Rate (CDR)	24.2 Percenage of participants Interval 17.83 to 31.59	24.8 Percenage of participants Interval 18.38 to 32.26	26.1 Percenage of participants Interval 19.49 to 33.58

SECONDARY outcome

Patient-level detection rate is defined as the percentage of participants who have at least one PET positive lesion, regardless of True Positive (TP) or False Positive (FP) findings, out of all participants who are scanned.

Outcome measures

Outcome measures
Measure	Central Reader 1 n=161 Participants Central Reading Center 1	Central Reader 2 n=161 Participants Central Reading Center 2	Central Reader 3 n=161 Participants Central Reading Center 3
Patient-level Detection Rate	31.7 Percentage of participants Interval 24.58 to 39.46	36.0 Percentage of participants Interval 28.62 to 43.95	40.4 Percentage of participants Interval 32.72 to 48.38

SECONDARY outcome

Region level sensitivity is defined as the percentage of regions that test positive on both vidoflufolastat (18F) and CTS (True Positive (TP)) among those regions that are CTS positive (True Positive (TP) or False Negative (FN)).

Outcome measures

Outcome measures
Measure	Central Reader 1 n=161 Participants Central Reading Center 1	Central Reader 2 n=161 Participants Central Reading Center 2	Central Reader 3 n=161 Participants Central Reading Center 3
Region-level Sensitivity of Vidoflufolastat (18F) (Overall)	53.2 Percentage of regions Interval 42.19 to 63.85	58.2 Percentage of regions Interval 46.69 to 68.81	58.0 Percentage of regions Interval 47.07 to 68.25

SECONDARY outcome

Region level specificity is defined as the percentage of regions that test negative on both vidoflufolastat (18F) and CTS (True Negative (TN)) among those regions that are CTS negative (False Positive (FP) or True Negative (TN)).

Outcome measures

Outcome measures
Measure	Central Reader 1 n=161 Participants Central Reading Center 1	Central Reader 2 n=161 Participants Central Reading Center 2	Central Reader 3 n=161 Participants Central Reading Center 3
Region Level Specificity of Vidoflufolastat (18F)	98.1 Percentage of regions Interval 96.77 to 98.85	97.1 Percentage of regions Interval 95.61 to 98.16	96.5 Percentage of regions Interval 94.94 to 97.66

SECONDARY outcome

Region level negative predictive value is defined as the percentage of regions that are CTS and vidoflufolastat (18F) negative (True Negative (TN)) among those regions that test negative on vidoflufolastat (18F) (True Negative (TN) or False Negative (FN)).

Outcome measures

Outcome measures
Measure	Central Reader 1 n=161 Participants Central Reading Center 1	Central Reader 2 n=161 Participants Central Reading Center 2	Central Reader 3 n=161 Participants Central Reading Center 3
Region Level Negative Predictive Value (NPV) of Vidoflufolastat (18F)	95.1 Percentage of regions Interval 93.26 to 96.4	95.5 Percentage of regions Interval 93.76 to 96.82	95.4 Percentage of regions Interval 93.56 to 96.73

SECONDARY outcome

Region level accuracy is defined as the percentage of regions that are CTS andvidoflufolastat (18F) positive (True Positive (TP)) and negative (True Negative (TN)) among those regions that identified on vidoflufolastat (18F) (True Positive (TP), True Negative (TN), False Positive (FP) and False Negative (FN)).

Outcome measures

Outcome measures
Measure	Central Reader 1 n=161 Participants Central Reading Center 1	Central Reader 2 n=161 Participants Central Reading Center 2	Central Reader 3 n=161 Participants Central Reading Center 3
Region Level Accuracy of Vidoflufolastat (18F)	93.7 Percentage of regions Interval 91.76 to 95.15	93.3 Percentage of regions Interval 91.32 to 94.86	92.7 Percentage of regions Interval 90.65 to 94.28

SECONDARY outcome

Patient-level positive predictive value related to PSA levels is defined as the percentage of participants who have at least one True Positive (TP) lesion (exactly anatomically localized correspondence between vidoflufolastat (18F) PET imaging and the reference standard), regardless of any co-existent False Positive (FP) findings, out of all participants who are vidoflufolastat (18F) positive, stratified by PSA levels. This endpoint was analyzed in each of the following subgroups: PSA ≤ 0.5 ng/mL; 0.5 ng/mL\<PSA≤1 ng/mL; 1 ng/mL\<PSA≤2 ng/mL; 2 ng/mL\<PSA≤5 ng/mL; PSA \> 5 ng/mL.

Outcome measures

Outcome measures
Measure	Central Reader 1 n=157 Participants Central Reading Center 1	Central Reader 2 n=157 Participants Central Reading Center 2	Central Reader 3 n=157 Participants Central Reading Center 3
Patient-level Positive Predictive Value (PPV) of Vidoflufolastat (18F) Related to PSA Levels Subgroup: 1 ng/mL <PSA <= 2 ng/mL (n = 11, 11, 11)	75.0 Percentage of Participants Interval 34.91 to 96.81	71.4 Percentage of Participants Interval 29.04 to 96.33	71.4 Percentage of Participants Interval 29.04 to 96.33
Patient-level Positive Predictive Value (PPV) of Vidoflufolastat (18F) Related to PSA Levels Subgroup: 2 ng/mL <PSA <= 5 ng/mL (n=11,11,11)	100 Percentage of Participants Interval 54.07 to 100.0	100 Percentage of Participants Interval 54.07 to 100.0	66.7 Percentage of Participants Interval 29.93 to 92.51
Patient-level Positive Predictive Value (PPV) of Vidoflufolastat (18F) Related to PSA Levels Subgroup: PSA <= 0.5 ng/mL (n = 100,100,100)	60.9 Percentage of Participants Interval 38.54 to 80.29	59.3 Percentage of Participants Interval 38.8 to 77.61	53.3 Percentage of Participants Interval 34.33 to 71.66
Patient-level Positive Predictive Value (PPV) of Vidoflufolastat (18F) Related to PSA Levels Subgroup: 0.5 ng/mL <PSA <= 1 ng/mL (n = 29, 29, 29)	100 Percentage of Participants Interval 66.37 to 100.0	66.7 Percentage of Participants Interval 34.89 to 90.08	76.9 Percentage of Participants Interval 46.19 to 94.96
Patient-level Positive Predictive Value (PPV) of Vidoflufolastat (18F) Related to PSA Levels Subgroup: PSA > 5 ng/mL (n = 6,6,6)	100 Percentage of Participants Interval 39.76 to 100.0	100 Percentage of Participants Interval 39.76 to 100.0	100 Percentage of Participants Interval 39.76 to 100.0

SECONDARY outcome

Timeframe: From first dosing (Day 1) up to 14 days post dosing

Population: Safety set (SAF): All participants who received at least one dose of vidoflufolastat (18F) or Gallium (68Ga) gozetotide. The vidoflufolastat (18F) Safety Set (F-SAF) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)). The gallium (68Ga) gozetotide safety Set (Ga-SAF) included all participants who received Gallium (68Ga) gozetotide.

An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject.

Outcome measures

Outcome measures
Measure	Central Reader 1 n=171 Participants Central Reading Center 1	Central Reader 2 n=178 Participants Central Reading Center 2	Central Reader 3 Central Reading Center 3
Overview of Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs) Adverse Events (AEs)	20 Participants	16 Participants	—
Overview of Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs) Treatment-related AEs	6 Participants	2 Participants	—
Overview of Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs) Serious Adverse Events (SAEs)	1 Participants	0 Participants	—
Overview of Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs) Treatment-related SAEs	0 Participants	0 Participants	—
Overview of Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs) Fatal serious AEs	0 Participants	0 Participants	—
Overview of Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs) Treatment-related fatal AEs	0 Participants	0 Participants	—
Overview of Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs) AEs leading to treatment discontinuation	0 Participants	0 Participants	—
Overview of Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs) Treatment-related AEs leading to treatment discontinuation	0 Participants	0 Participants	—
Overview of Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs) AEs leading to dose adjustment / interruption	0 Participants	0 Participants	—
Overview of Adverse Events (AEs) and Treatment Emergent Adverse Events (TEAEs) AEs requiring additional therapy	2 Participants	4 Participants	—

SECONDARY outcome

Population: The vidoflufolastat (18F) Safety Set (F-SAF) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)).

Inter-reader variability is defined as the agreement among three readers determination of vidoflufolastat (18F) images.

Outcome measures

Outcome measures
Measure	Central Reader 1 n=171 Participants Central Reading Center 1	Central Reader 2 Central Reading Center 2	Central Reader 3 Central Reading Center 3
Vidoflufolastat (18F) Scan Inter-reader Variability	65.5 % agreement Interval 56.84 to 74.15	—	—

SECONDARY outcome

Population: The vidoflufolastat (18F) Safety Set (F-SAF) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)). Scans for a subset of 19 participants from the vidoflufolastat (18F) safety set were read by each reader at 2 different time points

Intra-reader variability is defined as the within-reader agreement for two different time points of vidoflufolastat (18F) images.

Outcome measures

Outcome measures
Measure	Central Reader 1 n=19 Participants Central Reading Center 1	Central Reader 2 n=19 Participants Central Reading Center 2	Central Reader 3 n=19 Participants Central Reading Center 3
Vidoflufolastat (18F) Scan Intra-reader Variability	61.2 % agreement Interval 10.39 to 100.0	100 % agreement Interval 100.0 to 100.0	100 % agreement Interval 100.0 to 100.0

SECONDARY outcome

Population: The vidoflufolastat (18F) Safety Set (F-SAF) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)).

Concordance between vidoflufolastat (18F) and gallium (68Ga) gozetotide for detection of PSMA-positive lesions (location and number) using central reads.

Outcome measures

Outcome measures
Measure	Central Reader 1 n=171 Participants Central Reading Center 1	Central Reader 2 n=171 Participants Central Reading Center 2	Central Reader 3 n=171 Participants Central Reading Center 3
Concordance Between Vidoflufolastat (18F) and Gallium (68Ga) Gozetotide for Detection of Lesions at Lesion Level Using Central Reads (Overall)	51.1 Percentage of lesions Interval 40.62 to 61.49	48.2 Percentage of lesions Interval 38.86 to 57.66	55.1 Percentage of lesions Interval 44.41 to 65.36

SECONDARY outcome

Timeframe: From randomization up to 14 days after obtaining the results of the vidoflufolastat (18F) PET imaging

Population: The vidoflufolastat (18F) Safety Set (F-SAF) included all participants who received the investigational treatment (i.e. vidoflufolastat (18F)).

Change in patient management plans attributed to the PET/CT scan is defined as the percentage of participants who underwent a change in intended treatment plan attributed to the vidoflufolastat (18F) PET/CT scan as assessed by pre and post imaging questionnaires.

Outcome measures

Outcome measures
Measure	Central Reader 1 n=171 Participants Central Reading Center 1	Central Reader 2 Central Reading Center 2	Central Reader 3 Central Reading Center 3
Change in Patient Management Plans Attributed to the Vidoflufolastat (18F) PET/CT Scan	61 Participants	—	—

Adverse Events

Vidoflufolastat (18F)

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Gallium (68Ga) Gozetotide

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vidoflufolastat (18F) n=171 participants at risk Participants received vidoflufolastat (18F) on Day 1 or Day 15 (investigational imaging agent of interest)	Gallium (68Ga) Gozetotide n=178 participants at risk Participants received gallium (68Ga) gozetotide (as part of CTS if required, and for secondary endpoint) on Day 1 or Day 15
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.58% 1/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.

Other adverse events

Additional Information

Clinical Disclosure Office

Novartis Pharmaceuticals

Phone: 862-778-3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e., data from all sites) in clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER

Measure	Vidoflufolastat (18F) n=171 participants at risk Participants received vidoflufolastat (18F) on Day 1 or Day 15 (investigational imaging agent of interest)	Gallium (68Ga) Gozetotide n=178 participants at risk Participants received gallium (68Ga) gozetotide (as part of CTS if required, and for secondary endpoint) on Day 1 or Day 15
Blood and lymphatic system disorders Eosinophilia	0.58% 1/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Abdominal pain	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Constipation	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Diarrhoea	0.58% 1/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Flatulence	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Paraesthesia oral	0.58% 1/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
General disorders Asthenia	2.9% 5/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
General disorders Fatigue	0.58% 1/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
General disorders Injection site warmth	0.58% 1/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
General disorders Malaise	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
General disorders Thirst	0.58% 1/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations COVID-19	1.2% 2/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Injury, poisoning and procedural complications Wound	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Investigations Amylase increased	1.2% 2/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Investigations Blood creatine phosphokinase increased	0.58% 1/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Investigations Lipase increased	1.8% 3/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Musculoskeletal and connective tissue disorders Muscle spasms	0.58% 1/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Nervous system disorders Cognitive disorder	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Nervous system disorders Dizziness	0.58% 1/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Nervous system disorders Headache	0.58% 1/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Nervous system disorders Neuropathy peripheral	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Nervous system disorders Paraesthesia	0.58% 1/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Nervous system disorders Syncope	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Psychiatric disorders Apathy	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Renal and urinary disorders Haematuria	0.58% 1/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Renal and urinary disorders Renal pain	0.58% 1/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Vascular disorders Hypertension	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 2/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Vascular disorders Hypertensive crisis	0.00% 0/171 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/178 • Adverse Events (AEs) were collected from first dosing (Day 1) up to 14 days post dosing. Any sign or symptom that occurs during the conduct of the trial and safety follow-up.